As Life Science professionals with niche skills sets our clients are provided with an innovative, network based, qualitative service that produces results on hard to fill roles. The professionals we engage with are provided with invaluable technical and cultural insight into client companies ensuring they are sufficiently prepared to successfully engage in hiring processes. Our technical expertise across numerous verticals within the sector further enables us to interact on a meaningful basis with key decision makers so that we fully understand strategic technical and cultural fits.


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RECRUITMENT

CLIENT

Aphex’s industry experienced resourcing professionals have hands on experience working within Validation, Laboratories, Supply Chain, Procurement, Automation functions within the Life Sciences sector. Our professional qualification and verification approach ensures clients receive the most qualified professional. Contact us to manage your resourcing requirements.

PROFESSIONALS

Our value add is simple, you will be engaging with professionals that have proven and current experience of the Life Sciences industry with strong insights to client companies. This ensures that ambitious professionals are briefed and prepared accordingly throughout the rigours of the interview process, thus enhancing the probability of securing their next position.

PROFESSIONALS

Our value add is simple, you will be engaging with professionals that have proven and current experience of the Life Sciences industry with strong insights to client companies. This ensures that ambitious professionals are briefed and prepared accordingly throughout the rigours of the interview process, thus enhancing the probability of securing their next position.

AVAILABLE VACANCIES

Engineering Project Manager - Waterford City

Description:

Engineering Project Manager is responsible for the leadership of engineers and Project Management for new medical device manufacturing systems, products and cost improvements.

Responsibilities:

  • Use skills of analysis to identify, quantify and justify improvement opportunities.
  • Develop URS documentation for equipment and machine controls software systems.
  • Develop and implement new technologies and systems to support R&D projects.
  • Create and manage project schedules and budgets.
  • Communicate project information to all stakeholders (across many sites).
  • Identify, manage and mitigate project risk.
  • Identify and resolve project issues.
  • Demonstrate leadership skills to engage team members.
  • Demonstrate team building skills with motivated team members working well together.
  • Job will require travel to the USA and central Europe as project mix dictates.

Minimum Qualifications and Experience:

  • Bachelor level degree in Engineering or other relevant technical equivalent. Master qualification advantageous
  • 10+ years’ experience of project execution and supervision of engineers
  • Experience with medical device and/or pharmaceutical production required (cGMP / FDA regulated environment)
  • Knowledge of some of the following; software development life-cycle, GAMP V, SPC, DOE, Statistical Analysis, and Project Management (PMI certification a plus)
  • Project Management of high volume, low-cost manufacturing systems (may include pneumatics, PLCs, motion control, robotics, HMIs and SCADA)
  • Capable to lead, motivate and access engineers and others in project execution and technical development work streams
  • Self-directed. Excellent communication skills. Ability to form relationships with stakeholders from many sites and work within cross functional teams

 

Engineer - Process and Equipment - Waterford City

Description:

This position is to support manufacturing systems. Technical expertise is required to maintain, develop, debug and troubleshoot process & equipment issues.

Responsibilities:

  • Develop and implement process and equipment improvements with minimal impact to production operating under 24/7 environment.
  • Identify and eliminate repetitious machine failures.
  • Provide support to the Manufacturing, Maintenance, and Equipment Design groups.
  • Utilise Lean Six Sigma tools along with data to drive continuous improvement. Objective to minimise scrap, increase yield, reduce turn-around-time, minimise manufacturing downtime and costs and ensuring quality manufacturing within given specifications
  • Developing a detailed understanding of the process and automation systems in the manufacturing process, and sharing of technical expertise with colleagues.
  • Develop methods to ensure personnel engaged in maintenance activities have sufficient knowledge to perform their assigned tasks.
  • Generate documentation and SOPs associated with each of the equipment or process systems as required
  • Present, where appropriate, technical data to internal/external audit and inspection groups.
  • Ensure highest level of Health and Safety is considered and adhered to at all times for self and others
  • Equipment installation and validations
  • Process \ Equipment Engineers may lead projects \ project teams

Minimum Qualifications and Experience:

  • Bachelors in Engineering (mechanical\electronic) preferred.
  • A minimum of 4 years in technical role in high volume manufacturing environment preferred.
  • Good problem solving abilities – able to identify facts, consider alternative approaches and evaluate the most appropriate action.
  • Six sigma experience preferred.
  • Medical device and/or pharmaceutical industry experience preferred
  • Experience working in a validated environment with strong discipline with regard to change control is preferred.
  • Ability to share technical expertise with colleagues, must be able to express information clearly and concisely both verbally and in writing

 

Process Operator - Waterford City

Description:

Responsible for the operational activities within the company and as support to the project team. To ensure maximum production quality, while supporting the policies, goals and objectives of the company.

Responsibilities:

  • Health, Safety and the Environment
  • Comply at all times with the Health, Safety and Environmental policy and associated procedures.
  • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
  • Quality Compliance
  • Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, SOP’s and regulatory guidelines.
  • Take ownership for quality compliance in all activities you are responsible for.
  • Manufacturing Operations
  • To assist in the development of new SOPs/WIs as author and SME for production equipment and procedures.
  • To work with Operations team to maintain project schedule adherence through operational readiness preparation.
  • To manufacture and inspect Media Fill batches and subsequent GMP batches
  • Identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • Support Project delivery as needed through procedure development, FAT, SAT and validation of process equipment.
  • Pro-actively contribute in production incident investigations and problem solving sessions.
  • Actively participate in Tiered accountability meetings.
  • Communicate directly with the maintenance personnel to coordinate maintenance and repair work in manufacturing areas.
  • Perform preventative maintenance activities as required.
  • Assists maintenance technicians in performing maintenance and repairs.
  • Assists with diagnosing and trouble-shooting maintenance related issues

Minimum Qualifications and Experience:

  • Minimum 1 years’ experience within the pharma or biopharma sector
  • Experience in Sterile Manufacturing an advantage but not essential as a full training and development plan will be in place to upskill
  • Experience in Fill Line Operations, Formulation or Vial Inspection an advantage
  • Experience working on a project team an advantage
  • Experience in a startup facility an advantage

 

Maintenance Technician Fill Finish (Calibration / Instrumentation) - Waterford City

Description:

To ensure equipment is maintained and calibrated to meet engineering and GMP requirements. To support the Operation and Maintenance of equipment as part of the Sterile Operations Team.

Responsibilities:

  • Instrumentation, Maintenance and Operations:
  • Understand in detail how equipment operates.
  • Support the Sterile Operations Team in the reliable operation, maintenance and calibration of equipment
  • Carry out planned and reactive calibration/ maintenance as required.
  • Assist with the development of PM schedules for Fill Finish
  • Align Instrument calibrations with relevant Preventative Maintenance routines
  • Develop and comply with relevant SOP’s/WI’s.
  • Ensure spare parts requirements are available and cost effective for equipment
  • Support introduction of maintenance systems within Fill Finish
  • Support Project activities as required to ensure calibration and operational requirements are included. FAT attendance, commissioning and qualification support.
  • Procedure and Calibration assessments for new assets.
  • Problem solving techniques and associated skills are a requirement.
  • Health, Safety and the Environment:
  • Comply at all times with the Health, Safety and Environmental policy and associated procedures.
  • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
  • Quality Compliance:
  • Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, SOP’s and regulatory guidelines.
  • Take ownership for quality compliance in all activities you are responsible for.

Minimum Qualifications and Experience:

  • Undergoing or have a relevant third level qualification in Instrumentation or Engineering
  • Minimum 2 years’ experience within a relevant environment (preferably within a Pharma manufacturing environment)
  • Experience in a sterile Manufacturing environment would be an advantage
  • Experience in a facility start up would be an advantage
  • Technically, highly skilled in hands on Maintenance and Calibration
  • Attention to detail
  • Knowledge of Sterile Manufacturing
  • Multi-skilled – Electrical/Mechanical/Automation
  • Can interact with audits (internal and external) providing technical information
  • Proven track record of building relations with equipment vendors
  • Report writing skills

 

Senior Project Coordinator (Project Manager R&D) - Clonmel

Responsibilities:

  • Responsible for compliance with applicable corporate and divisional policies and procedures. Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort.
  • Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
  • Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
  • Assures project quality by using standard development methodologies and by working with the Supplier Quality Associate (SQA) to develop and execute project quality plans. Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings.
  • Resolves project issues by working with team members, project customers, and others as appropriate.
  • Participates in external project management organisations, conferences and seminars to keep current with industry best practices in project management by joining professional associations and implementing a professional development plan with focus on project management.

Minimum Qualifications and Experience:

  • National Framework of Qualifications level 7 qualifications in a relevant discipline.
  • 4+ years of related work experience or an equivalent combination of education and experience

 

Quality Assurance Manager (Lab Manager) - Clonmel

Description:

Provide management of a functional area that results in the implementation and achievement of vision, mission, and functional objectives. This position is responsible for overseeing and directing quality engineering, regulatory compliance, analytical laboratories, product release and quality control functions. Plans, develops and manages the quality organisation to assure the continuance of qualified and efficient staff to meet Corporate, Food and Drug Administration (FDA), and International Organisation for Standardisation (ISO) requirements as well as other regulatory requirements as captured in COP381.

Responsibilities:

  • Recruits, coaches and develops organisational talent.
  • Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organisational objectives.
  • Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees.
  • Keeps the organisation’s vision and values at the forefront of decision making and action.
  • Demonstrates effective change leadership.
  • Builds strategic partnerships to further departmental and organisational objectives.
  • Develops and executes organisational and operational policies that affect one or more groups by utilising technical/professional knowledge and skills.
  • Makes decisions regarding work processes, operational plans and schedules in order to achieve department and site objectives.
  • Develops, monitors and appropriately adjusts the annual budget for the areas of operation.
  • Participates with manufacturing management at all levels in problems relating to quality, compliance and reliability.
  • Oversees the completion of the annual product review as requested. Establish and maintain effective structures to ensure consistent implementation of the quality system for the company as the site of legal manufacture.
  • Monitors compliance with company policies and procedures (for example; compliance with Food and Drug Administration (FDA), International Standards Organisation (ISO), Equal Employment Opportunity (EEO) regulations and standards, etcetera) and escorts inspectors/auditors for third party and unannounced inspections/audits.
  • Approves documents defining the quality system and can own documents.
  • Coordinates where required audits by external bodies to the site and supports audits as requested across the division.
  • Ensures where applicable that the internal audit schedule is executed in a timely and effective manner.
  • Drives continuous improvement / Corrective Action Preventive Action (CAPA) and validation initiatives.
  • Ensure that valid test data is used for all regulatory submissions.
  • Responsible for development and execution of a robust supplier evaluation and monitoring programme ensuring that quality materials and services are used onsite; achieved through periodic assessment and communication of supplier performance.
  • Reviews subcontractors, suppliers and service providers quality systems to ensure that purchased product fully complies with the specified requirements.

Minimum Qualifications and Experience:

  • Experience/Education
  • National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline and 9+ years of related work experience or an equivalent combination of education and work experience.
  • Set Vision & Strategy
  • Identifies and acts upon trends that can impact the business. Creates and communicates a motivating, compelling vision of the future that supports employee engagement. Develops short and long-term strategies and helps align the resources to achieve them. Translates strategies into actionable goals and plans, and then communicates them to ensure alignment of effort and purpose Cognitive skills
  • Anticipate
  • Develops scenario and contingency plans that ensure achievement of results under changing conditions and situations. Takes initiative to implement change before others. Actively gathers customer inputs in order to anticipate and fulfill their needs and requirements. Manages internal/external stakeholders to identify and address issues. Understands the situation or audience and adjusts approach to achieve desired outcomes.
  • Innovate
  • Creates an environment of experimentation and uses failure as an opportunity to learn and take alternate action. Challenges current thinking; generates new ideas and expects others to do the same. Integrates information from multiple sources to generate unique insights or new solutions that distinguish the company from the competition. Leverages diversity of people and thinking to create a competitive advantage. Collaborates across boundaries to create cross-business opportunities.
  • Build
  • Creates a sustainable infrastructure and environment that enables growth. Maintains leadership presence and emotional control in difficult situations. Provides the insight, knowledge and leadership to improve functional area and build the business. Develops, rewards and shares talent; is the type of leader others want to work with or for. Provides accurate, frequent and constructive feedback to subordinates, peers and leaders. Makes the difficult people, financial and business decisions in a timely manner.
  • Deliver Results
  • Displays continuous energy, intensity and persistence to drive the organisation forward. Delivers what is promised; holds self and others accountable for results, commitments and behaviours. Takes appropriate accountability for failure; does not blame others. Takes action in a timely manner, with urgency or caution as appropriate, but always in a planned way. Balances short and long-term priorities and maximises the opportunities for both. Addresses organisational or cultural barriers that could prevent success.
  • Supervision Received
  • Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long-term perspective, for desired results.
  • Supervision Provided
  • Provides direction and guidance to exempt specialist and/or supervisory personnel who exercise significant latitude and independence in their assignments; evaluates performance of and assists in career development planning for subordinates; often responsible for a centralised staff or professional function of the company.

 

Molding Engineer - Clonmel

Description:

Plays a leading role in the area of the company’s injection molding related activities, including new tool qualifications and resolution of supply and quality issues encountered during day-to-day running of the business.

Responsibilities:

  • Responsible for design, development, implementation and ongoing support of polymer-based injection molded components used in the manufacture of the company’s products offerings.
  • Serve as both technical expert in the field of injection molding as well as a project manager for molding related projects, working regularly with Research and Development (R&D), Operations, Supply Chain, Quality and suppliers.
  • Manage molded commodities over life cycle including tactical and strategic activities to support ongoing business such as product, process, quality and cost improvement initiatives, supplier and resin changes, material obsolescence.
  • Troubleshoot molding issues in conjunction with supplier and lead/support internal investigations as required.
  • Work closely with molding suppliers to ensure reliable supply of parts.
  • Responsible for ensuring adherence to quality system through creation and update of specifications, metrology, setup, design control and qualification and Failure Models and Effects Analysis (FMEA)
  • Identify critical dimensions and work with suppliers to ensure proper process controls are in-place.
  • Must have proven ability to participate in team atmosphere, exhibit and create a sense of urgency and maintain effective working relationships with peers, customers and suppliers.
  • Concurrent management/support of multiple projects.
  • Create and maintain project schedules, lead and participate in cross-functional team activities to achieve program objectives.’
  • Transfer of molds to new suppliers, start-up of new suppliers.
  • Participate in cross-functional teams to investigate and resolve molding issues.
  • Perform capacity analysis for molds, presses and assembly automation and make recommendations for future investment.

Minimum Qualifications and Experience:

  • Experience/Education
  • National Framework of Qualifications (NFQ) Level 7 qualification in a relevant discipline
  • 4+ years of relevant work experience or an equivalent combination of education and work experience.
  • Technical/Business Knowledge (Job Skills)
  • Wide application of technical principles, practices and procedures within the field of polymer component manufacture, in particular within the field of injection molding. Strong understanding of business unit functions and cross group dependencies/ relationships. Will perform role within quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Cognitive skills
  • Works on problems of diversive scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact.
  • Influence/Leadership
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments. Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. Interacts frequently with suppliers.
  • Planning/Organization
  • Plans and organizes non-routine tasks. Initiates or maintains work schedule. Establishes priorities of work assignments.
  • Decision making/Impact
  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure or resources.
  • Supervision Received
  • Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
  • Supervision Provided
  • May provide work direction and guidance to exempt and/or skilled non-exempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.

 

Senior Category Procurement Specialist - Clonmel

Description:

Responsible for obtaining services, materials, components, and equipment. Checks requisitions, obtains quotations, examines bids, and makes awards. Develops new supply sources where vendors and suppliers are inadequate. As required, monitors the cost, schedule, and scope of assigned subcontracts to assure best quality at best value. May evaluate vendor reliability. Co- ordinates activities involved with procuring goods and services (for example, raw materials, equipment, tools, parts, supplies and travel services) and ensures that items and services purchased are of high quality, on time and at the lowest total price.

Responsibilities:

  • Interacts with suppliers and providers by phone or in person to negotiate activities involved with procuring materials and service. Requests bids from new suppliers by personal contact and/or phone to ensure the best price for materials.
  • Assists internal and external customers by answering questions and assisting in solving their problems so they can perform within established guidelines (for example, Good Manufacturing Practices, (GMP) Food and Drug Administration (FDA), travel and expense policy).
  • Implements cost saving ideas to obtain maximum efficiencies of company funds.
  • Conducts supplier audits by visiting their facility, observing task performance and reviewing procedures to evaluate their capabilities.
  • Audits various forecasts, patterns, and reports to ensure inventory demands are met and/or company service provided to employees meets business need.
  • Identifies invoice discrepancies (for example, duplicate billing, price differences and quantity errors) by researching process steps and/or interfacing with appropriate departments to resolve the problem.
  • Investigates non-conforming materials by interfacing with production engineers, receiving personnel, and/or suppliers to identify the cause.
  • Maintains manual and/or computerised records of activities (for example, items/services purchased, costs, delivery, travel patterns, product quality/performance and inventories) to provide accurate information source.
  • Provides written data (for example, memos, letters and purchase orders) to departments and suppliers to convey company needs and requirements.
  • Processes purchase requests by accessing database and assigning a number to the order to provide an information source for tracking the order.

Minimum Qualifications and Experience:

  • Experience/Education
  • NFQ level 7 qualification in a relevant discipline and 5+ years of related work experience, or an equivalent combination of education and work experience.
  • Technical/Business Knowledge (Job Skills)
  • Working knowledge and application of business concepts, procedures and practices. Will perform this job in a quality system environment.
  • Cognitive skills
  • Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment.
  • Influence/Leadership
  • Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks. May demonstrate basic project management skills by acting as a project lead on small, well defined projects. Provides guidance to less experienced staff. Influence exerted at peer level and occasionally at first levels of management.
  • Planning/Organization
  • Plans, organises, and prioritises own daily work routine to meet established schedule.
    Decision making/Impact
  • Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays and may result in the allocation of additional resources.
  • Supervision Received
  • Works under general supervision. Receives limited supervision on standard issues, and detailed instructions on new assignments. Work is reviewed for soundness of judgment, overall adequacy and accuracy.
  • Supervision Provided
  • May provide limited work direction and guidance to exempt and/or skilled non-exempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.

 

EHS Group Lead - Clonmel

Description:

Lead EHS team to design, develop and implement site Environmental, Health & Safety programs. The Group Leader provides direction and actively supports subordinates and maximizes results through an efficient use of budgeted resources.

Responsibilities:

  • Provide overall leadership, strategy development and EHS compliance assurance with respect to:
  • Generation of an EHS culture onsite, fostering the principles of participation, compliance and continuous improvement.
  • Leadership in the development and implementation of proactive EHS management systems which facilitate compliance, are cost effective, protect the employee’s health and safety and manage our impact on the environment.
  • Leadership in the development of long-range plans to address current and future EHS issues facing the site and the divisions and development of management communications on these topics.
  • Participation in the negotiation of compliance issues with regulatory agencies as necessary and track any response to citations/violations should they occur.
  • Provision of a technical/regulatory resource in the areas of EHS and the interpretation of analytical data to determine EHS control measures, etc.
  • Project management relating to EHS investigations.
  • Manage EHS program for continuous improvement, facilitating involvement of all employees.
  • Manage site EHS training process and programs to ensure effectiveness and compliance of EHS education.
  • Support plant processes related to EHS to ensure consistency and continuous improvement.
  • Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
  • Work with the company and Corporate to maximize standardization/efficiencies and to communicate/represent the site at these levels.
  • Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
  • Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled non-exempt staff to achieve unit or project goals.
  • Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures
  • Contributes to the development and monitoring of area budgets through regular analysis of cost and spending. Translates department goals into individual objectives and KRAs (key result areas).
  • Identifies, develops and implements processes to improve department performance.

Minimum Qualifications and Experience:

  • Experience/Education
  • NFQ (National Framework of Qualifications) level 7 qualification in a relevant discipline.
  • 6+ years of related work experience or an equivalent combination of education and work experience.

 

  • Technical/Business Knowledge (Job Skills)
  • Monitors progress of exempt individuals, teams, supervisors or non-exempt technical individuals toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility.
  • Will perform this job in a quality system environment.
  • Failure to adequately perform tasks can result in noncompliance with governmental regulations

 

  • Cognitive skills
  • Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned area or related departments; facilitates others involvement in the continuous improvement program; investigates and solves problems that impact work processes and personnel within the assigned unit.

 

  • Influence/Leadership
  • Promotes the attainment of group goals by selecting, motivating, and training capable staff. Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives.

 

  • Planning/Organization
  • Schedules human and material resources within a group or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget.

 

  • Decision making/Impact
  • Assignments are expressed in the form of tasks and objectives; generally makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management, consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.

 

  • Supervision Received
  • Works under minimal supervision.
  • Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.

 

  • Supervision Provided
  • Provides direction and guidance to supervisors, experienced exempt and/or skilled non-exempt levels of employees; evaluates performance of and assists in career development planning for subordinates; often responsible for a local functional or process activity.

 

Maintenance Technician - Waterford City

Description:

To ensure equipment is Maintained to the highest standards possible through systematic predictive maintenance, preventative maintenance and repairs.

Responsibilities:

  • Maintenance and Operations
  • Understand in detail how equipment operates. (Chiller, steam boilers, HVAC, Compressed air systems, Electrical distribution, back up generation, production manufacturing equipment namely compression and encapsulation)
  • Support Predictive/ preventative maintenance methodologies including the initial set up of a Maintenance Management system.
  • Develop and comply with relevant SOP’s.
  • Ensure spare parts requirements are available and cost effective for equipment.
  • Develop Spare parts lists for various equipment as required.
  • Effective problem solving and reactive maintenance as required.
  • Measurement of equipment performance in terms of downtime, yield if applicable, efficiency and cost of Maintenance.
  • Developing relationships with Vendors and developing Maintenance contracts.
  • Ensure the preventative maintenance routines are executed on time and in a compliant manner.
  • Health, Safety and the Environment
  • Comply at all times with the Health, Safety and Environmental policy and associated procedures
  • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
  • Quality Compliance
  • Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, SOP’s and regulatory guidelines.
  • Take ownership for quality compliance in all activities you are responsible for.

Minimum Qualifications and Experience:

  • Senior trades (Fitter), and/or a relevant third level qualification in Mechanical or Manufacturing discipline.
  • Minimum 5 year’s engineering experience within a relevant environment (preferably within a Pharma manufacturing environment)
  • Packaging experience would be an advantage
  • Safety and cGMP compliance.
  • Ability to understand engineering processes through a logical, data driven approach.
  • Technically, highly skilled in hands on Maintenance.
  • Attention to detail
  • Multi-skilled – Electrical/Mechanical

 

Site Shift Lead - Meath

Description:

The Site Shift Lead will lead all manufacturing operations as well as support activities on their designated shift for our new state of the art single use multi-product biotech facility in County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for the leading global biotech company focused on rare diseases. Key responsibility includes leading a team of manufacturing, maintenance, automation and quality professionals who are responsible for the day to day shift operations at the site. This role will ensure that all aspects of the Meath culture including commitment to safety, right first time in everything we do and a focus on the engagement and development of employees is prioritised. This role is a critical role on the manufacturing leadership team as well as the most senior person on shift at the site.

Responsibilities:

  • SAFETY
  • Member of the site emergency response team, act as site Incident Commander in the event of an accident or incident on site.
  • Perform safety audits, walk downs and leads on safety investigations on shift – report and resolve any unsafe operations.
  • Build safety as a value within every aspect of the value stream supporting manufacturing operations that ensure sustainable EHS programmes that are engrained and deployed into each area.
  • Liaise with statutory agencies as required – and acts as primary site contact with agencies in the off hours.
  • Responsible for ensuring compliance with legal, EHS and all company policies and procedures which are applicable to the site.
  • PEOPLE
  • Ensure that all employees on shift supporting manufacturing are working as one team to support the delivery of product to patients.
  • Be responsible for the shift skills matrix to drive a learning and development organisation as well as maximising flexibility across the shift team.
  • Coach and mentor all employees on shift including all indirect employees supporting the value stream.
  • Support the creation of a high performing site organisation through implementation of a robust learning and development plan for the shift team, providing feedback to all employees on shift and the implementation of a robust communication plan to the shift including 1:1s, skip levels, development planning, and regular site updates.
  • Celebrate with use of proactive recognition tools that inspire teams and individuals.
  • Create an environment where everyone speaks up for safety and looks out for one another.
  • Be an ambassador for the company leadership behaviours of accountability, be positive, results driven and excellent manager of self and others.
  • Role model the behaviours that creates a culture of respect and dignity in line with the company guide to ethical conduct.
  • Responsible for the goal setting, ongoing performance reviews and development planning of each employee on shift.
  • OPERATIONS
  • Lead the site shift operations ensuring that all manufacturing operations are completed to schedule. This includes completion of batch record review, investigations and the completion of all scheduled activities including sampling, cleaning, preventative maintenance, calibration, changeovers, validations and projects.
  • Provide timely visibility through tier meetings and visual management on progress against value stream KPIs, delays, action plans, improvement opportunities and recognition.
  • In partnership with the manufacturing leadership team create and sustain a culture of excellence in safety, quality and continuous improvement.
  • Create an environment of right first time in everything that we do through a focus on principles of lean including simplification, standard work, visual management and a learning organisation as part of the tier meeting structure and ensure shift automation and process engineering are engaged in making changes/ improvements that support right first time improvement and error proofing.
  • Be accountable for a robust investigation process to drive to right first time.
  • Ensure objectives are aligned, integrated across the shift team, translated to all and visually managed to drive delivery.
  • Deliver on the annual business plan including all KPIs related to safety, quality, people and productivity in partnership with the site manufacturing leadership team and the value stream leadership team.
  • Represent the Meath plant internally and externally to promote the Meath plant as a great place to work and to support delivery of benchmark site performance.
  • Responsible for ensuring compliance to all requirements of current Good Manufacturing Practice.
  • Strengthening overall leadership and organizational capabilities in area of responsibility.
  • Be ready and capable of leading on discussions with auditors on plant based activities and in leading on audit walk downs.
  • Play a key role in delivering the start-up plan for the site, acting as an area SME during the handover process from commissioning through into qualification and process validation.

Minimum Qualifications and Experience:

  • A Level 8 Bachelor of Science or Engineering degree or equivalent is required.
  • Demonstrated capability in Bio-Pharmaceutical Manufacturing / Engineering or other relevant technical experience (up to 9 years)
  • Strong ability to lead a team of highly engaged employees
  • Thorough knowledge of current Good Manufacturing Practices (cGMP) and general technical and biologic operations understanding required.
  • Experience working in an automated facility would be a distinct advantage
  • Key Skills and Competencies:
  • Ability to translate the vision and goals of the company and site to the shift team.
  • Enterprise mind-set to ensure the right prioritisation for the manufacturing operations.
  • Strong planning and project management skills to support delivering the integrated manufacturing schedule.
  • Strong stakeholder management skills to manage stakeholders across the various function’s that support manufacturing.
  • Strong Talent Developer with a focus on creating a continuous learning organisation through active coaching
  • Demonstrated capability to lead a team of highly engaged employees.
  • Excellent influencing/collaboration skills and teamwork mind-set.
  • Excellent trouble shooting and problem-solving skills as well as ability to coach and mentor teams through complex problems.
  • Ability to challenge the status quo with a continuous improvement mind set.
  • Proven ability to using a wide variety of lean tools and building capability in teams you have led.
  • Change agent who will support the organisation with good change management tools and techniques.
  • Effective communicator.
  • Proven ability to grow talent.
  • Promoting a culture where diversity and inclusion is supported.
  • Ability to drive implementation of lean automated process through standard work, tier meetings, visual management and problem solving
  • Complexity and Problem Solving:
  • Identifying and communicating risks in delivery of the manufacturing schedule.
  • Creating action plans to manage risk to the operations.
  • Internal and External Contacts:
  • For Quality Organisation partner with QA Operations Support to ensure that all GMP activities that support manufacturing of product at the Meath plant are done in a consistent, compliant and a timely manner.
  • Provide support to QA on shift through a robust communication plan and ensuring they are integrated as part of the shift team.
  • For Manufacturing, Science & Technology (MS&T) collaborate to ensure the required technical support is available to the shift team during complex events including validation runs, implementation of new technology or major investigations.
  • Collaborate with Manufacturing HR Business Partner to ensure recruitment, learning and development of all employees on shift is prioritised.
  • Collaborate with other members of the manufacturing leadership team to ensure that all activities that are required to support an efficient and effective manufacturing schedule are delivered including master manufacturing recipe, change control, investigation management, projects, and master production schedule.
  • For Maintenance support the shift maintenance team to ensure preventative maintenance and calibration schedules are maintained and provides support in terms of shift priorities.
  • For Automation support the shift automation engineer in terms of priorities for actions that support closeout of action items and process improvements.
  • For Supply Chain collaborate to ensure all processes and systems supporting planning, purchasing and warehousing, distribution are developed and tracked to support PAI readiness and commercial manufacture.

Maintenance and Reliability Manager - Waterford

Description:

The Maintenance and Reliability Engineering Manager has overall responsibility for the maintenance and reliability of all production equipment at the Waterford Site. This includes the management of the Crafts headcount and all the associated reporting and budgetary requirements

Responsibilities:

  • The Maintenance and Reliability Engineering Manager has overall responsibility for the sites Maintenance Department budget
  • Ensuring, along with the relevant Process Engineering Managers, that the sites manufacturing equipment performance meets or exceeds all required KPI
  • Management of all Safety and Quality regulatory requirement
  • Provide strategies to ensure all raft training has been identified and support the ongoing skills enhancement of Crafts and non-technical members of Maintenance teams
  • Ensure planned preventative maintenance is executed to plan and plans are in place to ensure regulatory conformance always
  • Periodic maintenance systems review, identification and execution of continuous improvement projects focused on equipment performance, application of best practice maintenance strategies to sustain these improvements long term
  • Optimization of MRO stores stock levels, collaborate with cross functional teams to ensure critical spare parts are identifies and in stock
  • Ensure all maintenance work performed onsite exceeds Health & Safety and Quality requirements

Minimum Qualifications and Experience:

  • Batchelor Degree in Engineering or another relevant technical equivalent
  • 3+ years supervisory experience, or hands on preventative / reactive maintenance, technician management within a unionised environment
  • 5+ Years’ experience of engineering / maintenance roles in high volume regulated industries with a significant technology content
  • Extensive hands on experience of high speed; highly automated manufacturing and packaging lines is a distinct advantage
  • Knowledge of medical device and/ or pharmaceutical production or alternative regulated environment (cGMP / FDA regulated)

QC Specialist for LIMS - Meath

Description:

This role will support the Quality Control functional testing of incoming raw materials, in-process drug substance/drug product, final drug products, stability samples and environmental monitoring of the controlled manufacturing areas and utilities at the new single-use multi-product biotech facility. This facility will manufacture enzyme replacement and antibody-based therapies for a leading global biotech company focused on rare diseases. The overall responsibility for this role will be to support the Quality Control testing function, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.

Responsibilities:

This role is associated with the data management systems for instrument control in the laboratories, this includes but is not limited to Labware LES (LIMS + Execution System), Lonza MoDa, Waters Empower, Mettler Lab-X. Below activities are associated with these systems;

  • Participates in defining user requirements.
  • Tests and validates the design.
  • Develops procedures and training documents.
  • Assist in the implementation at site.
  • Gather raw data for template building.
  • After vendor provided training will provide the first line of support within their laboratories.
  • Empower superuser to build and maintain custom calculation builds and system maintenance.
  • Reviewing analytical data, analytical reports and performing peer reviews.
  • Instrument qualification, maintenance and troubleshooting.
  • Protocol generation– method verification/transfer.
  • Providing training for team members.
  • Following all relevant Standard Operating Procedures.
  • Ensuring strict adherence to site policies, GMP and environmental, health and safety regulations.
  • Complies with all pertinent regulatory agency requirements.
  • Execution and on-time completion of required training activities.
  • Conducts thorough data review to ensure completeness and accuracy of records.
  • Reviews test results to ensure compliance with standards; reports any quality anomalies.
  • Participates in Laboratory Investigations as required.
  • Writes and revises control test procedures and SOPs as required.
  • May interact with outside customers or functional peer groups.
  • Promotes and exhibits company Values.
  • Executing company policies.
  • Ensuring self -inspections are performed.
  • Ensures new/revised quality system requirements are deployed to the Site

Minimum Qualifications and Experience:

  • A Level 8 Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering etc).
  • Previous GMP laboratory experience in the biotechnology and/or pharmaceutical industry.
  • Excellent communication skills (written and oral).
  • An understanding of cGMP requirements for manufacturing and/or systems and compliance.
  • Required to work on his/her own initiative in addition to working as part of a team.
  • Excellent time management & organisational skills.
  • An understanding in analytical methodology (e.g. HPLC, ELISA, SDS-Page, Glyco analytic, Bio- Assays, PCR, capillary electrophoresis, compendial assays).
  • A working understanding of GMP, ICH, USP and global compendia regulations and guidance’s, particularly as related to analytical method development and validation.
  • Previous experience with laboratory management systems such as LIMS/ MoDa/ Lab-X and / or Empower systems and interest in coding/ script.

Key Skills & Competencies:

  • Excellent trouble-shooting and problem-solving skills.
  • Ability to challenge the status quo with a continuous improvement mindset.
  • Promoting a culture where diversity and inclusion is part of the DNA.

Complexity & Problem Solving:

  • Identifying and communicating risks in area of responsibility and across the site.
  • Creating strategies and plans to manage risk within the Quality Control operation.

Internal and External Contacts:

  • For product quality, collaborates with Manufacturing, Science & Technology (MS&T) and Manufacturing Operations but is responsible for providing information to support the QMR decision.
  • For quality and compliance, collaborates with the QMR but accountable for creating a ‘right first time’ culture in the Quality group to support quality excellence.
  • For safety, the individual is accountable to drive a culture of ‘everyone owns safety’ with input from the EHS lead.
  • For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in the company and through external forums to drive business excellence in Quality Assurance.

Order to Cash Project Manager - Meath

Description:

Reporting to the Invoice-to-Cash Director, the main purpose of the role is to manage all ITC projects, RPA and continuous improvement initiatives while ensuring controls are in place, performed and all related documentations are up-to-date and passed appropriately to the team.

Responsibilities:

  • Lead the GBS SAP deployment/continuous improvement initiatives for the Invoice-to-Cash area and future related area projects
  • Develop Impact Assessment / Workstream project plans
  • Define & signoff Solution Design / Represent GBS in SAP Workshops
  • Define Testing Scope & Test Scripts
  • Coordinate User Acceptance Testing within GBS Operations
  • Responsible for analyzing and documenting “As Is” and “To Be” processes and procedures
  • Provide summaries of Project Key Performance Indicators (KPIs) and performance statistics to identify key areas of opportunity, ensuring that concise and accurate information is available for informed management decisions making purposes.
  • Work across Business Process & Technology Owners (and teams) to provide end customers with a reliable quality solution fit for purpose
  • Work with project and program manager to drive deadlines, commitments, and manage inter-dependencies / risks
  • Communications: Develop, deliver and maintain communication plans and channels for all internal and external stakeholders.
  • Manage and Coordinate updates to SOPs/WIs/RACI and training materials as required
  • Manage Process flows and updates as required
  • Support Invoice To Cash (ITC) operations as required and transfer of new developments, changes to the team – includes training documentation
  • Lead RPA journey for ITC

Minimum Qualifications and Experience:

Required:

  • Graduate in Finance, IT or equivalent qualification
  • 5 years of working in Finance with AR experience in Credit & Collection, Billing, Sales & Distributions Modules
  • Good working knowledge of AR & SD module in SAP key
  • Experience in data conversion, integration and project implementation & management
  • Strong project methodology experience
  • Strong order management experience
  • Strong Excel skills, and good knowledge of MS office overall RPA experience
  • Good financial knowledge of aspects relevant to the O2C cycle

 Preferred:

  • ACCA, CIMA or equivalent finance qualification
  • Previous finance SSC Experience in a large multinational centre
  • Experience and understanding of pharmaceutical industry strongly preferred
  • Project Management qualification (PMP/Prince or equivalent)
  • VBA experience

Key Skills and Competencies:

  • Driven and committed – able to work on own initiative under pressure and to demanding deadlines.
  • Flexible – willing to work in a “hands-on” manner to ensure that all tasks are achieved by the teams on a timely basis.
  • Open and communicative – able to interact effectively at all levels of the organization.
  • Strong analytical skills – able to identify anomalies in data and solve them quickly and effectively.
  • High level of accuracy and attention to detail.
  • Strong customer service focus – understand customer needs and possess the desire and ability to meet and exceed those expectations, demonstrating a high commitment to quality delivery.

Complexity and Problem Solving:

  • Managing multiple projects in parallel
  • Development and implementation of processes to create internal efficiencies while control and reporting delivery is not compromised

QA Specialist - Quality Control - Dublin

Responsibilities:

  • Responsible for quality oversight of all Quality Control related activities supporting the technical transfer, qualification and testing of all company products. Scope includes both Clinical and Commercial products, Drug Substance, Drug Product, finished product, stability programme and raw material.
  • Provide Quality oversight of Quality Control related activities at the facility.
  • Provide Quality oversight and leadership on all Quality Control site transfer related activities at the facility.
  • Provide quality oversight and leadership in the requirements of Quality Control related change controls and deviations.
  • Provide QA oversight of change controls, Laboratory Investigation Reports, deviations, Quality Control SOP’s, technical transfer documentation, validation and qualification documentation and test related documentation.
  • Provide QA and compliance support to equipment and process qualifications.
  • Participate on cross functional project teams as required.
  • Ensure quality KPIs in relation to QC activities are met.

Minimum Qualifications and Experience:

  • Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
  • Experienced QA professional with both QA Operations and QC Analytical experience
  • 3-5 years’ experience in QA positions preferably QC operations of pharmaceutical and/or biotech products
  • Previous experience in technical transfer activities
  • Sound awareness and understanding of current quality and regulatory requirements
  • Familiarity in the use of enterprise systems for the management of product and associated records and quality documentation.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
  • Excellent interpersonal, management skills and high professional standards for customer service and work quality; must be highly self-aware and receptive to feedback and continuous improvement
  • Excellent problem-solving, critical thinking, deductive reasoning, inductive reasoning, and analytical skills
  • Exceptional written and oral communication skills, including the ability to communicate technical or financial information to a non-technical audience
  • Experience with relevant HR systems, applications, and tools; metrics, data, and business intelligence tactics; and continuous improvement strategies
  • Superior project management skills, particularly with respect to organization, prioritization, and time management

Instrumentation Engineer - R&D Analytical - Waterford City

Description:

Provide technical support to the Laboratory departments at the facility by maintaining all laboratory instrumentation in an operational & qualified state. This role will ensure that both instrument hardware and software qualifications are completed in a timely manner. This role includes, but is not limited to activities in the following areas:

Introduction, set up and commissioning of new instrumentation.

Maintenance and calibration of existing instrumentation.

Administration and maintenance of Laboratory instrumentation software systems excluding Empower.

Responsibilities:

  • Essential duties and responsibilities include, but are not limited to, the following:
  • Develop, maintain and execute all instrumentation calibration & maintenance schedules ensuring that all stake holders are kept informed where required.
  • Perform all necessary internal instrument calibrations & maintenance, for example monthly calibration of balances, UV, FT-IR, etc.
  • Organise & manage the identification, evaluation, purchasing, installation & qualification of any new laboratory instrumentation along with all relevant documentation.
  • Organise, supervise and approve all external maintenance & calibrations carried out by external vendors on Laboratory instrumentation.
  • Develop & write all necessary SOP’s & validation protocols relating to the operation, qualification and maintenance of all laboratory instrumentation as necessary.
  • Develop a working knowledge of all instrumentation software platforms and troubleshoot them as necessary.
  • Perform/participate in instrument/method trouble shooting as required.
  • Represent the Instrumentation Laboratory function at all project meetings both internal and external as required, feeding back status updates to the group when necessary.
  • Ensure all work is carried out in compliance with the required standards, conforming to company, cGxP, SOPs and regulatory regulations and guidelines.
  • Produce and maintain accurate, GMP compliant records.
  • Identify & make recommendations for improvements within or outside the department in order to ensure the continuous improvement of the company.
  • Health and Safety
  • Ensure requirements of the company’s Safety Statement are implemented.
  • Implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
  • Report any instrument defects or site hazards.
  • Continuously promote a positive safety culture by leading by example.

Minimum Qualifications and Experience:

  • Requires BSc in Chemistry or related discipline; may consider another qualification with relevant experience.
  • 3 – 5 years relevant experience in a cGMP environment is required
  • Experience in any of the following would be considered advantageous:
  • Prior experience in maintenance, qualification and calibration of laboratory instrumentation.
  • Prior experience in laboratory software administration
  • Working knowledge of change controls and risk assessments
  • Prior experience in project management

Skills:

  • Troubleshooting of Analytical Instrumentation
  • Operational knowledge of laboratory instrumentation such as HPLC, UV, FT- IR, Dissolution Bath etc.
  • Operational knowledge of laboratory computerised systems e.g. Empower.
  • Computer skills and Project Management.

Materials Purchasing Specialist - Athlone

Responsibilities:

  • Complete end to end purchasing activities in accordance with applicable procedures, corporate policies, and cGMP requirements for direct and indirect raw materials in support of site Operations.
  • Work with Manufacturing and other site departments to understand future material needs and develop and manage a purchasing schedule.
  • Process purchase requisitions, enter purchase orders in SAP, and generate reports for upper management review.
  • Trend vendor issues and manage supplier performance and KPI’s for business review meetings with vendors.
  • Support Raw Materials and SAP Process teams – identify problems, recommend process improvements, and work with the team on resolutions.
  • Resolve invoice discrepancies by working directly with the vendor, internal requisitioner and corporate Accounts Payable.
  • Work closely with internal stakeholders such as Manufacturing, Planning, Operations, Quality Departments, and Finance and Flag any supply issues as appropriate in a timely manner.
  • Action MRP output as appropriate and manage the Direct Materials Supply Chain;
  • Set up and maintain material master data for existing and new material introductions.
  • Manage the introduction of new material and vendor set up for AAMF.
  • Manage Bill of material’s creation, up keep, changes on an ongoing basis.
  • Weekly release of manufacturing Bills of materials to meet AAMF’s annual production schedule.
  • Track all new material introduction for the Fill finish/Biologics plant ensuring effective timelines/deadlines are achieved.
  • Track Vender change notifications and ensure company policies are followed.
  • Provide Material and Logistical input and oversight for all start-up project activities through to commercial readiness and ongoing product disposition.
  • Ensure incoming inspection activities for all materials and components are completed in line with all GMP and regulatory requirements.
  • Responsible for change controls, deviations and CAPA’s related to Materials and Logistics for the Athlone Facilities.
  • Develop and implement appropriate metrics and key performance indicators.
  • Review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports to meet the needs of Clinical and Commercial Operations groups.
  • Actively contributes to continuous improvement activities.
  • Lead all environmental material initiatives and material safety related items

Minimum Qualifications and Experience:

  • 3rd level qualification in Business, Materials Management, Operations or Supply Chain Management/Logistics or other equivalent such as APICS qualification.
  • 0 – 3 years of purchasing experience in a Biopharmaceutical or Pharmaceutical environment, preferred.
  • Proficient in use of Microsoft Office suite – Excel, Powerpoint, Word.
  • Understanding of cGMP Raw Material purchasing requirements.
  • Excellent interpersonal and communication skills.
  • Customer service oriented, self-starter, responsible and accountable for scope, and able to work on problems of moderate scope involving various cross-functional groups.

Supplier Quality Engineer - Clonmel

Description:

Provides technical support in the selection and approval of suppliers and service providers by performing supplier evaluations. Monitors supplier performance to drive supplier corrective action. Conducts supplier certification activities. Drives improvement and corrective action in the quality of components sourced from outside suppliers.

Responsibilities:

  • Assesses potential new suppliers and service providers for technical quality and quality systems capabilities. Determines method of evaluation and forwards either a correspondence questionnaire to the supplier or conducts an on-site audit.
  • Prepares and audit report that establishes the outcome of the audit and details the non-conformances identified during the on-site audit. Works closely with suppliers to obtain an appropriate written corrective action response plan with estimated dates for completion. Tracks audit results, including corrective actions and provides follow-up to these actions, as required.
  • Evaluates Exception Reports (ERs) issued for nonconforming supplied material and prepares Supplier Corrective Action Requests (SCAR) to effect resolution of root cause problems contributing to unsatisfactory supplier quality performance.
  • Maintains an active role with new products development teams to assist in supplier selection and approval and provide support, as required. Applies the appropriate engineering discipline to assure acceptable products or services and to resolve quality issues.
  • Prepares data for presentation at the Corrective and Preventive Action (CAPA) meetings summarizing the results and status of corrective and preventive actions initiated with suppliers to strive for improvement.
  • Ensures that the supplier performs and documents the appropriate engineering approach to activities such as qualification/validation and provides assistance in these efforts, as appropriate.
  • Conducts field visits of supplier sites to bring understanding and resolution of quality problems.
  • Uses computer software to measure, track and trend supplier quality performance and provide feedback to the organization and to the supplier for continuous improvement.
  • Conducts certification activities to upgrade approved suppliers to certified supplier status.
  • Notifies suppliers of customer complaints related to device failures resulting from supplied material and requires investigation and corrective action.

Minimum Qualifications and Experience:

  • Experience/Education: National Framework of Qualifications (NFQ) level 7 in a relevant discipline, 2+ years of related work experience, or an equivalent combination of education and work experience
  • Technical/Business Knowledge (Job Skills): Working knowledge and application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Cognitive Skills: Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Have a general knowledge of technical alternatives and an understanding of their impact on the systems environment.
  • Influence/Leadership: Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate the completion of tasks. May demonstrate basic project management skills by acting as a project lead on small, well defined projects. Provides guidance to less experienced staff. Influence exerted at peer level and occasionally at first levels of management.
  • Planning/Organization: Plans, organizes and priorities own daily work routine to meet established schedule.
  • Decision Making/Impact: Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays and may result in the allocation of additional resources.
  • Supervision Received: Works under general supervision. Receives limited supervision on standard issues and detailed instructions on new assignments. Work is reviewed for soundness of judgment, overall adequacy and accuracy.
  • Supervision Provided: May provide limited work direction and guidance to exempt and/or skilled non-exempt levels of employees. May be asked to evaluate performance of and assist in career development. planning for subordinates.
  • The availability to travel both within Ireland and internationally will be required as part of this role.

Documentation Specialist - Dublin

Description:

This position is responsible for actively participating in continuous improvement process mapping events and translating the output of those events into Standard Operating Procedures (SOP) and Work Instructions (WI). In this role, you should have excellent technical writing skills, relationship building and problem-solving skills. A high attention to detail and excellent verbal and written communications skills are vital to success in the role. High proficiency in MS word is essential.

Responsibilities:

  • Active participation in Continuous Improvement Projects
  • Writing and revision of Standard Operating Procedures (SOPs)
  • Track documents through approval process and work with approvers to deliver documents in line with Quality Control project plans
  • Provide training of revised/new procedures/processes to company staff
  • Identify process improvements within the function and drive the initiative forward to implementation and effectivity
  • Comply with internal SOP’s, standards and associated training
  • Support the Quality Control, with responsibility to develop processes
  • Responsible for assigned CAPA’s, Change Controls & Deviations program and initiate
  • Corrective Action plans in the company’s Quality Management System, TrackWise
  • Maintain regular and proactive communication with all stakeholders

Minimum Qualifications and Experience:

  • At least 5 years’ working in Pharmaceutical quality operations
  • Degree in science/pharmaceutical related subject
  • Knowledge and understanding of GMP/GDP standards
  • Strong problem-solving experience
  • Familiar with continuous improvement initiatives
  • Experience of SOP authoring and document management processes
  • Highly Computer literate, with MS Office (Word, Excel)
  • Experience of provision training to others
  • Experience of working in a GMP Quality Control Laboratory or Quality Assurance Unit

Laboratory Investigation Specialist - Dublin

Description:

This position is responsible for conducting and documenting investigations associated with the company’s Quality Control Laboratory – Laboratory Investigation Reports (LIRs) and deviations In this role, you should have excellent investigational, root cause analysis and problem-solving skills. Relationship building, a high attention to detail and excellent verbal and written communications skills are vital to success in the role.

Responsibilities:

  • Conduct and document investigations associated with the company’s Quality Control Laboratory in a complaint and timely manner
  • Conduct root cause analysis
  • Develop and document Corrective and Preventative Actions (CAPAs) and associated CAPA
  • Effectiveness Checks (EC)
  • Track and trend investigations and associated root cause types
  • Provide training and mentoring for Laboratory Staff
  • Identify process improvements within the function and drive the initiative forward to implementation and effectivity
  • Comply with internal SOP’s, standards and associated training
  • Support the Quality Control, with responsibility to develop processes
  • Responsible for assigned LIR, CAPA’s, Change Controls & Deviations program and initiate
  • Corrective Action plans in the company’s Quality Management System, TrackWise
  • Maintain regular and proactive communication with all stakeholders

Minimum Qualifications and Experience:

  • At least 5 years’ working in Pharmaceutical quality operations
  • Degree in science/pharmaceutical related subject
  • Knowledge and understanding of GMP standards
  • Strong problem solving experience
  • Familiar with continuous improvement initiatives
  • High level of experience of conducting Laboratory Investigations, root cause analysis and CAPA development
  • Highly Computer literate, with MS Office (Word, Excel)
  • Experience of provision training to others
  • Experience of working in a GMP Quality Control Laboratory or Quality Assurance Unit

Senior Quality Engineer - Clonmel

Description:

Provide process & quality engineering support to manufacturing, helping to ensure delivery of the highest quality product to customer. Provide process & quality engineering support to product development teams, helping to ensure development of the highest quality of new products.

Responsibilities:

  • Identify the manufacturing process defects (scrap, non-conforming material and customer complaints) by dispositioning non-conforming material, identifying primary root causes and suggesting corrective and preventative actions. May be responsible for querying and bounding data to support implementation of basic product stops.
  • Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members.
  • Develops process monitoring systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.
  • Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
  • Assists in creation of quality tools and training materials by understanding the limitations of existing quality tools and training materials and by helping to identify more effective tools and materials.
  • Participates in validation activity Role may very between providing input to owning activities such as protocol/report writing and managing execution of validation actives.
  • Participates in corrective and preventative action activity.

Minimum Qualifications and Experience:

  • National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline and 5+ years of related work experience.
  • Wide application of technical principals, practices and procedures. Strong understanding of business unit function and cross group dependencies knowledge and application of concepts, practices and procedures.
  • Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Works on problems of diverse scope where analysis of situations or data requires a review of identifiable factors
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.
  • Plans, organised and prioritises non routine tasks with approval.
  • Exercises judgement in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
  • May provide work direction and guidance to varied levels of employees.

Senior Internal Auditor - Clonmel

Description:

As a key member of the Regulatory Compliance team, ensure that the site is in compliance with applicable Corporate, FDA and International Regulatory requirements. Perform assessments of the company’s quality system to determine whether it is in compliance with the established requirements and to evaluate its effectiveness. Incumbent is responsible for the site Internal Audit Program. This role will require up to 50% travel across company sites globally.

Responsibilities:

  • Audits areas of the company’s quality system, as assigned.
  • Audits Commercial affiliate locations
  • Develops audit plans including scope and objectives. Creates audit checklists based on assigned area, applicable regulations, and pertinent company quality system/ procedural requirements, and obtains approval from RC Manager as appropriate.
  • Evaluates the adequacy and compliance of systems, operations, and practices against regulations and site documentation.
  • Documents identified non-conformities and obtains concurrence with responsible management.
  • Communicates final results of audits to responsible management internally and elevates to Division as needed.
  • Tracks issues through to closure including reviewing the corrective action taken.
  • Oversees follow-up of corrective actions and audit closure, including escalating overdue or at risk items as necessary.
  • Responsible for the site Internal Audit Program. Must adhere to the Divisional Internal Audit schedule and deliver high quality reports on time.
  • May serve as escort to inspectors or assessors from regulatory agencies or notified bodies.
  • Serves as Subject Matter Expert in company Quality System processes/procedures during internal/ external audits and to other business units as requested.
  • Conducts and documents Corrective and Preventive (CAPA) investigations for any audit findings in area of responsibility or as assigned.
  • Approves CAPA investigations in the system as required per procedure or as needed.
  • Supports site and Divisional Quality Systems projects as needed.
  • Develops and provides training on cGMPs and Quality System procedures as needed.
  • Supports Supplier Quality Engineering function by performing supplier audits as needed. Serves as Supplier Quality Engineer backup.

Minimum Qualifications and Experience:

  • National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline and 4+ years of related work experience.
  • A minimum of 8 years of related work experience in medical devices (preferably) or other FDA-regulated industry is required. Incumbent must have extensive experience on performing internal audits, managing external inspections/responses and be proficient in CAPA processes.
  • Strong understanding of specified area (Technical/Business Knowledge.)
  • Requires very strong leadership skills to positively influence others across departments and sites while conducting internal audits and defining/implementing required corrective/ preventive actions.
  • Incumbent must establish an extensive network of support in the site and across the Division to facilitate the completion of assignments. May participate in the development of less experienced staff providing guidance and offering counsel. May lead a project team. Should be able to influence management on technical and/or business solutions. May interact with suppliers.
  • Must be very organized and have strong planning skills to work on routine and non-routine tasks.
  • Ability to work on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercise judgement within generally defined practices and policies and selecting methods and techniques for obtaining solutions.
  • Ability to work in diverse cross-functional team environment.
  • Excellent written and verbal communication skills.
  • Detailed oriented.
  • Effective management of MS Office Applications – Word, Excel, Power Point.

Quality Assurance Specialist, Quality Control - Dublin

Description:

The QA Specialist for Quality Control will be responsible, with management support, for providing oversight of quality activities associated with the quality control processes at the manufacturing facility. The Specialist will contribute and guide completion of milestones associated with specific projects and support ongoing quality assurance responsibilities in support of but not limited to quality control processes at the manufacturing facility. The QA specialist will be required to support as required, packaging activities and quality systems including Change Control, Deviations and CAPA’s. Act independently to determine methods and procedures on new assignments and provide guidance to other personnel as required. Perform all responsibilities in accordance with company policies, procedures, and regulations.

Responsibilities:

  • Serve as Quality Assurance SME for quality control activities maintaining knowledge of industry standards and regulatory requirements to ensure all quality control activities are compliant.
  • Active member of the QA Operations team ensuring on-time disposition of finished product. This should be achieved through completion of the following activities:
  • Review and assess QC deviations; including performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
  • Review and assess QC Laboratory Investigations
  • Review and approve QC generated Corrective and Preventive Actions (CAPA); including tracking, follow-up, and reporting/trending and evaluating CAPAs for effectiveness.
  • Provide Quality support to QC department in method transfer or validation activities.
  • Support the work of the Quality Systems and Compliance team by the coordination and optimization of Quality Management Records relating to Deviation, Change controls and CAPA.
  • Support Global Complaints Handling Unit (GCHU) in complaint investigations.
  • Supports the business through coordination of day to day operations and change management relating to Quality e-Systems such as TrackWise
  • Generation, development and communication of Site Quality Metrics and measurements to support the on-going development of site compliance.
  • May create or revise standard operating procedures relating to various quality system elements
  • Represents Quality Assurance to guide various projects and technical meetings, as needed
  • Responsible for documenting and reporting compliance issues to management.

Minimum Qualifications and Experience:

  • Minimum of B.S. degree in Chemistry, Biology or related field
  • Minimum 3 years of experience in QA and/or QC.
  • Further technical training in the areas of problem solving, risk assessment would be an advantage
  • Thorough knowledge of cGMP/GLP/GDP and international regulatory requirements.
  • Demonstrated ability to coordinate and drive improvement in processes supporting Quality Systems or Quality Control.
  • Proven ability to identify, influence and drive process improvement.
  • English fluency written and spoken (the Company language). Efficient in SAP, firstdoc. and Trackwise® would be an advantage.

New Process Development Manager - Clonmel

Description:

New role to support the automation of drug spray and optimizing existing operations processes. Manage a team of 5 people to run a range of technical projects responsible for project delivery and budgetary requirements. Provides support to the manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met. Monitors performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Interfaces with research and development organizations to integrate new products or processes into the existing manufacturing area. In addition to the above, this position will focus on automation of new and existing processes on site.

Responsibilities

  • New process development in automated drug coating to deliver significant cost reduction in the manufacturing process
  • Taking a lead role in development of project plan and execution of same from concept through to commercialization
  • Coordinating resourcing with multi-site stakeholders to meet project deadlines
  • Management, Leadership and motivation of a highly technical team of 5 to deliver on project goals’
  • Delivery of timely and accurate reporting on project delivery to senior leaders
  • Provide direction on preparation of key Process Documents, including Business Requirements Documents, Risks and Issues Logs and Project Plans
  • Managing relationships with internal customers throughout the life cycle of the project to ensure all business needs are met
  • Significant budgetary responsibility

Experience:

  • Technical/Business Knowledge (Job Skills)
  • Monitors progress of exempt individuals, teams, supervisors or non-exempt technical individuals toward departmental goals
  • Monitors costs of projects and of human and material resources within a department or unit, monitors external environment in area of technical or professional responsibility
  • Will be performing this job in a quality system environment
  • Failure to adequately perform tasks can result in noncompliance with governmental regulations
  • Cognitive Skills
  • Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned area or related departments, facilitates others involvement in the continuous improvement program; investigates and solves problems that impact work processes and personnel within the assigned unit.
  • Influence/Leadership
  • Promotes the attainment of group goals by selecting, motivating, and training capable staff.
  • Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives.
  • Planning/Organization
  • Schedules human and material resources within a group or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget.
  • Decision Making/Impact
  • Assignments are expressed in the form of tasks and objectives, generally makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management; consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.
  • Supervision Received
  • Works under minimal supervision. Independently determines and develops approach to solutions.
  • Work is reviewed upon completion for adequacy in meeting objectives.
  • Supervision Provided
  • Provides direction and guidance to supervisors, ex experienced exempt and/or skilled non-exempt levels of employees; evaluates performance of and assists in career development planning for subordinates; often responsible for a local functional or process activity.

Qualifications/Training:

  • Third level degree in Mechanical, Manufacturing, Production Engineering or similar discipline. A qualification in Project Management is an advantage.
  • Min 3 years experience in product / process development with Class II / III medical devices. Experience in Automation & Controls is an advantage but not essential
  • A proven ability to deliver highly visible and business critical projects on time and within budget.
  • Proven track record of success as a Project Manager coupled with strong relationship building skills, including written, face-to-face and remote (conference call/phone based).
  • Have a thorough and practical understanding of project lifecycles and the delivery of parallel cross-functional projects.
  • Demonstrated track record on project delivery
  • Ability to prioritize and to remain results orientated.
  • Strong analytical, verbal and written communications skills.
  • Strong technical competencies
  • Ability to effectively communicate to multi-function stakeholders at all levels of the organization

Automation Controls Engineer - Waterford City

Description:

The successful candidate would execute projects in a fast paced, multi-disciplined, cross- functional team environment

Responsibilities:

  • Develop and implement new technologies, controls and vision systems to improve cost and quality of existing strategic medical device products.
  • Facilitate internal resources and outside vendors in developing technical solutions for automated equipment. Interface with equipment vendors to ensure successful machine delivery, integration and manufacturing validation.
  • Develop specifications documents for new equipment and work closely with vendors to ensure the software related systems are correctly developed as per specifications.
  • Provide technical expertise in the validation of new technologies to ensure they meet the Safety, Quality and Operational requirements specified.
  • Develop and manage project schedules/detailed work plans in order to meet overall project goals. Communicate status of project activities on a regular basis.
  • Support product, platform and cost improvement programs by delivering qualified vision systems and acquisition software, machine controls and PLC/SCADA software. Interface with SQA, QA and Operations groups to successfully validate software systems. Author and execute software test scripts as required.
  • Identify improvement opportunities and provide business case analysis to quantify and justify automation projects.
  • Provide automation requirements and implement solutions for product lines and/or capacity expansions.
  • Provide technical and controls core competency support, including training to Operations and Engineering personnel on an as-needed basis, including possible off-hours, remote and onsite coverage rotation.
  • Travel to vendor locations for project reviews may be required.

Minimum Qualifications and Experience:

  • Degree in Electrical, Electro-Mechanical, Computer Systems or Electronic Engineering or other similar technology degree – or equivalent training/experience
  • Experience in high volume low cost manufacturing systems development desirable
  • Knowledge of software development life cycle methodologies, statistical analysis and machine vision fundamentals advantageous
  • Must be able to work with Operations staff, Manufacturing/Maintenance technicians and engineers in cross-functional team setting.
  • 5+ years’ experience with development, integration and project management of automated control systems including Vision systems, PLC’s, motion control, robotics, HMI’s and SCADA control systems software
  • Experience with equipment build, process automation, machine vision systems development and medical products advantageous.
  • Experience working in a cGMP/FDA regulated environment desirable

Fill Finish Validation Specialist - Dublin

Description:

The Senior Specialist Technical Services has primary responsibility for providing technical support of commercial and clinical drug product manufacturing operations performed at contract manufacturing organisations (CMOs). The successful candidate will be responsible for providing scientific and engineering support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation and routine commercial or clinical manufacturing. The position requires effective cross-functional collaboration with CMOs and internal partners including Manufacturing, Process Development, Engineering, and Quality to provide support of manufacturing.

Responsibilities:

  • Provide significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and late stage clinical products at CMOs.
  • Lead troubleshooting efforts and high-level deviation investigations in conjunction with contractors and internal partners (Process Development, Manufacturing, and Quality).
  • Support all aspects of the manufacturing process from raw material selection and specification through formulation and filling to visual inspection, testing and release.
  • Technical review of change controls for impact to product quality, safety and efficacy.
  • Provide on-floor technical support and troubleshooting at the CMO facility.
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.
  • Collection, organisation, trending, and analysis of GMP manufacturing data.
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
  • Support establishment of validation plans and evaluation of drug product production site options
  • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
  • Up to 25% international travel required.

Minimum Qualifications and Experience:

  • Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
  • Minimum of five years’ experience in in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
  • Experienced in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product drug manufacturing operations are cGMP compliant.
  • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
  • Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes (CQA).
  • Experience of working with CMOs would be a distinct advantage, demonstrating strong communication and influencing skills.

Validation Engineer (Pharma) - Cork

Description:

The Validation Engineer is the technical owner and SME of the site Utility systems. Responsible for all quality and compliance issues, including deviation reporting and investigation, safety incidents, technical support and project support. Responsible for the HSE critical instrumentation, approval of all calibrations across the Technical Services department, and the Single Point of Contact (SPOC) for the site personal gas detector fleet. Responsible for ensuring that equipment is in compliance with all regulatory, statutory and client corporate requirements.

Responsibilities:

  • Day-to-day relationship with client engineering manager and team
  • Technical ownership of the site HVAC, and will ensure all HVAC systems are up to date with respect to GMP and FDA guidelines, as well as statutory and client corporate and local requirements
  • The Plant Compliance Engineer – is involved in Technical Service projects and issues (deviations, safety incidents etc.) across the site and potentially off site. This also includes trouble-shooting and high-level investigation of all related plant equipment faults and failures
  • The Plant Compliance Engineer – is responsible for numerous HSE critical instruments used to maintain the sites compliance with its Industrial Emissions Licence and will be required to discuss and defend these in front of auditors.
  • Responsibility for approval of all Technical Services calibrations on the computerised calibration system as well as being the SPOC for the site personal gas detector fleet.
  • Responsible for ensuring that all maintenance, preventative and unplanned, of assigned equipment/systems is completed on schedule, within budget, in a safe and satisfactory manner and all necessary documentation is completed.
  • Supporting site contract maintenance team in minimizing downtime and risk of downtime to facility
  • Updating of utilities related standard operating procedures
  • Identifying, liaising with, and, where appropriate, co-ordination of third party contractors and suppliers on site.
  • Liaising with site contract team to identify suppliers and quantities of spare parts; review and updating of spare part inventory of spares in clients site store.
  • Liaising with contract team and client to review maintenance programme, and effecting changes to methods and procedures where appropriate
  • Monitoring progress & quality of assigned tasks carried out by Projects, AIT and/or other departments.
  • Assisting client personnel with writing User Requirement Specifications for all systems under scope, and advising client representatives, where appropriate, of engineering requirements in User Requirement Specs for new equipment.
  • Identifying and implementing, where appropriate, energy saving schemes
  • Liaising with Quality and external auditing bodies upon audits.
  • Management of audit action items generated from various site, corporate, cGMP and EHS audits.
  • Ensuring Engineering areas, in liaison with Contract Manager and Contract co-ordinator, facilities and equipment are kept in a clean, safe and serviceable condition, and general housekeeping high standards are maintained.
  • Applying site standards and ensure standards are applied by others within the team.
  • Training of engineering and operation personnel on discipline related issues and assigned new or modified equipment/systems.
  • Contributing to process improvement/optimisation from an engineering viewpoint
  • Analysis of new technology for optimisation of plant and processes
  • Ensure that the maintenance standards adhere to the high cGMP and quality standards set on site.
  • Compliance with all Client & statutory standards
  • Ensure all SOPs and documents relating to maintenance are compliant.
  • Ensure all maintenance personnel are actively involved in Quality programs on site.

Minimum Qualifications and Experience:

Essential:

  • Engineering degree or equivalent, preferably mechanical/building services, with five years plus post graduate experience, or
  • Marine qualification or Trade qualification (National Craft Cert, City & Guilds or Equivalent), preferably mechanical/building services, with eight to ten years post apprenticeship experience.
  • A strong project management background and understanding of commissioning and qualification based on the ISPE Baseline Guide, Volume 5.
  • Maintenance and troubleshooting experience of the following systems and processes: HVAC; RO/Purified Water; Plant Steam; Clean Steam; LPHW and DH&CW Systems; Compressed Air; Process gases; Power distribution; Building Management Systems; Validation

Desirable:

  • Maintenance and troubleshooting experience of the following systems and processes – Waste water treatment, solvent recovery, incineration; pharma water and steam systems, fire suppression systems.
  • Design and/or modification of any/all of the above systems.

QC Chemist – Fill Finish – Waterford City

Purpose:

To support Product Development, Clinical Supply and launch of Parenteral Products. To Support Fill Finish Quality related tasks.

Responsibilities:

  • To draft/ review test methods.
  • To take part in laboratory and operation investigations as required.
  • To liase directly with customers and contract laboratories and attend conference calls as required.
  • To attend internal project review meetings as required.
  • To assist in the preparation for customer/ regulatory inspections. 
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • To ensure that all work is carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • To complete all documentation correctly, in line with data integrity guidelines, free from errors, omissions or defects in order to achieve a high level of customer service and cGMP. To peer review documentation as required.
  • To perform additional team tasks as agreed to support effective running of the Business.
  • To support all other on-going laboratory functions & requirements.
  • To perform AQLs as required on Raw Material and Finished Products.
  • To perform inspection of Stability and Retention samples as required.
  • To support Fill Finish with Foreign matter investigations. (Identity, trending and Investigations)
  • Health and Safety
    • To ensure the requirements of EirGen’s Safety Statement are implemented.
    • To continuously promote a positive safety culture by leading by example.
    • To implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
    • To report any defects/hazards

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline
  • Strong analytical ability.
  • Strong quality orientation.
  • Good time management.
  • Strong attention to detail.
  • Good problem solving abilities.
  • Excellent organisational skills.
  • Ability to multitask and work under pressure, coping with more than one conflicting task at once.
  • Excellent communication skills, both verbal & written.
  • Adaptability – ability to maintain effectiveness in varying environments and with different tasks, responsibilities and people
  • Ability to work effectively with a team to accomplish organisational goals
  • Proficient in the use of electronic document management systems.
  • Proficient in Technical report writing
  • Strong Safety awareness.
  • Knowledge & proficiency of Microsoft products for example MS Excel, Word & Project, Power-point.

R&D Sterile Formulation Lead - Waterford City

Description:

To support the R&D department by providing significant fill-finish technical expertise to support all aspects of the formulation & manufacturing of sterile products. As a key member of the R&D team, your role is to provide leadership, cross-functional development and technical expertise on the aseptic manufacture sterile formulations

Responsibilities:

  • SME for sterile formulation of small molecule and biologic products
  • Apply a thorough knowledge of pharmaceutics to the development of drug products and the interpretation of in-vitro data to predict in-vivo performance.
  • Interpret in-vitro data for the purposes of further formulation development.
  • Provide scientific leadership across all the disciplines involved in Sterile Operations
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure
  • Support all aspects of the manufacturing process from formulation development through to filling & lyophilisation
  • Technical review of change controls for impact to product quality, safety and efficacy
  • Provide on-floor technical support and troubleshooting
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities
  • Collection, organisation, trending, and analysis of GMP manufacturing data
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices
  • Ensure information transfer to Process Engineering group for all cycle development activities
  • Ensure appropriate scientific documentation is collated and approved for a robust Process Flow document
  • Ensuring that operational modifications or processing gaps are identified and updated in the operational control strategy
  • Lead technical feasibility review and technology gap analysis for new product introductions
  • Escalation of issues to the Sterile Technical Operations Manager, as appropriate
  • Communication of project data through presentations at internal meetings and through formulation development reports
  • Provide guidance and lead pivotal scale cGMP exhibit batch manufacture based upon a sound knowledge of site and departmental SOPs, and an understanding of ICH/FDA/EMEA requirements as they relate to formulation and process development activities
  • Maintain a comprehensive knowledge of formulations and process development disciplines through research and scientific literature

Technical Expertise:

  • Extensive operational experience within aseptic filling lines and formulations areas
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Sterile filling processes and equipment
  • Pharmaceutical and Biotechnology formulation & manufacturing processes
  • Technical Primary pack knowledge and vendor knowledge (WEST, Schott, OMPI, etc.)
  • Demonstrable analytical and systematic problem solving skills

Skills/Qualifications:

  • Qualified to Honours Degree level in an appropriate science discipline
  • Minimum five years’ experience in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection
  • Significant exposure to sterile operations and/or Tech Transfer projects
  • Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations
  • Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing and the ability to implement best practices
  • Experience of technology transfers and implementing new clinical and commercial manufacturing processes, specifically sterile liquid fill operations
  • Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes
  • Excellent knowledge of MS Office
  • Excellent knowledge of project management techniques and tools (e.g. MS Project)
  • Customer relations management (internal & external)
  • Multi-tasking, ability to manage conflicting deadlines
  • Excellent written, oral, interpersonal and presentation skills
  • Conflict management
  • Excellent computer skills to include MS office, ECDL certification an advantage
  • Proven time management skills
  • Planning & organizing
  • Project management
  • Knowledge of electronic document management system

Intermediate Molding Engineer - Clonmel

Description:

Provides support in the area of injection molding related activities, including new tool qualifications and resolution of supply and quality issues encountered during day-to-day running of the business.

Responsibilities

  • Supports implementation and ongoing use of polymer-based injection molded components used in the manufacture of products
  • Supports molded commodities over lifecycle including product, process, quality and cost improvement initiatives, supplier and resin changes
  • Troubleshoot molding issues in conjunction with supplier and lead or support internal investigations as required.
  • Work closely with molding suppliers to ensure reliable supply of parts.
  • Responsible for ensuring adherence to quality system through creation and update of specifications, metrology setup, design control and qualification and Failure Modes and Effects Analysis (FMEA).
  • Identify critical dimensions and work with suppliers to ensure proper process controls are in place.
  • Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
  • Interacts cross-functionally with internal and external customers and suppliers. Serves as a consultant for engineering or scientific interpretations and advice on significant matters.
  • Concurrent support of multiple projects.
  • Understands engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a breakthrough in technology.
  • Cultivates internal and external network of resources to complete tasks. May lead a project team, determining goals, objectives and managing schedules for the projects.

Qualifications:

  • Experience/Education
  • National Framework of Qualifications (NFQ) Level 7 qualification in a relevant discipline
  • 2+ years of relevant work experience or an equivalent combination of education and work experience.
  • Technical/Business Knowledge (Job Skills)
  • Working technical knowledge and application of principles, practices and procedures within the field of polymer component manufacture, in particular injection molding. General understanding of business unit functions and cross group dependencies/ relationships. Will perform this role within a quality system environment. Failure to adequately perform tasks can result in non-compliance with governmental regulations.
  • Cognitive skills
  • Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgement within defined procedures and practices to determine appropriate action. Must have a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
  • Influence/Leadership
  • Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks. May lead a project team of moderate scope. Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. Influence exerted at peer level and occasionally at first levels of management.
  • Planning/Organization
  • Plans, organises and prioritises own daily work routine to meet established schedule.
  • Decision making/Impact
  • Exercises authority and judgement within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
  • Supervision Received
  • Works under general supervision. Follows established procedures. Work is reviewed with soundness of technical judgement, overall adequacy and accuracy.
  • Supervision Provided
  • May provide limited work direction and guidance to exempt and/or skilled non-exempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.

Technical Services Specialist (Process Engineer) - Athlone

Description:

The Technical Services Specialist has responsibility for providing technical support to clinical and commercial drug product manufacturing activities at the manufacturing facility. The successful candidate will be responsible for providing technical support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation and routine commercial or clinical manufacturing. The position requires effective cross-functional working relationships with Manufacturing, Engineering, Facilities, Logistics, Quality Assurance and Quality Control groups which support day- to-day operations; interacting with Process Development and Analytical sciences for introduction of new products; and providing support for Regulatory submissions and inspections related to commercial and clinical products.

Responsibilities:

  • Provide significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and future late stage clinical products at the Athlone Facility
  • Support technology transfers of new products into the Athlone Facility
  • Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.)
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure.
  • Support all aspects of the manufacturing process from raw material selection and specification through formulation and filling to visual inspection, testing and release.
  • Technical review of change controls for impact to product quality, safety and efficacy.
  • Provide on-floor technical support and troubleshooting.
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.
  • Collection, organisation, trending, and analysis of GMP manufacturing data.
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
  • Support establishment of validation plans and evaluation of drug substance/product production site options
  • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated in Athlone
  • Any other duties as required by management

Minimum Qualifications and Experience:

  • Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
  • Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
  • Experienced in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection. Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices
  • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
  • Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes (CQA).

Senior Molding Engineer - Clonmel

Description:

Plays a leading role in the area of injection molding related activities, including new tool qualifications and resolution of supply and quality issues encountered during day-to-day running of the business.

Responsibilities:

  • Responsible for design, development, implementation and ongoing support of polymer-based injection molded components used in the manufacture of our client’s products offerings.
  • Serve as both technical expert in the field of injection molding as well as a project manager for molding related projects, working regularly with Research and Development (R&D), Operations, Supply Chain, Quality and suppliers.
  • Manage molded commodities over life cycle including tactical and strategic activities to support ongoing business such as product, process, quality and cost improvement initiatives, supplier and resin changes, material obsolescence.
  • Troubleshoot molding issues in conjunction with supplier and lead/support internal investigations as required.
  • Work closely with molding suppliers to ensure reliable supply of parts.
  • Responsible for ensuring adherence to quality system through creation and update of specifications, metrology, setup, design control and qualification and Failure Models and Effects Analysis (FMEA)
  • Identify critical dimensions and work with suppliers to ensure proper process controls are in place.
  • Must have proven ability to participate in team atmosphere, exhibit and create a sense of urgency and maintain effective working relationships with peers, customers and suppliers.
  • Concurrent management/support of multiple projects.
  • Create and maintain project schedules, lead and participate in cross-functional team activities to achieve program objectives.
  • Transfer of molds to new suppliers, start-up of new suppliers.
  • Participate in cross-functional teams to investigate and resolve molding issues.
  • Perform capacity analysis for molds, presses and assembly automation and make recommendations for future investment.

Minimum Qualifications and Experience:

  • Experience/Education
  • National Framework of Qualifications (NFQ) Level 7 qualification in a relevant discipline
  • 4+ years of relevant work experience or an equivalent combination of education and work experience.
  • Technical/Business Knowledge (Job Skills)
  • Wide application of technical principles, practices and procedures within the field of polymer component manufacture, in particular within the field of injection molding. Strong understanding of business unit functions and cross group dependencies/ relationships. Will perform role within quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Cognitive skills
  • Works on problems of diversive scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact.
  • Influence/Leadership
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments. Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. Interacts frequently with suppliers.
  • Planning/Organization
  • Plans and organizes non-routine tasks. Initiates or maintains work schedule. Establishes priorities of work assignments.
  • Decision making/Impact
  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure or resources.
  • Supervision Received
  • Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
  • Supervision Provided
  • May provide work direction and guidance to exempt and/or skilled non-exempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.

Sterilisation Engineer - Clonmel

Description:

Provides technical support specific to terminal sterilisation activities to facilitate efficient operations, to optimise existing processes, and to ensure that production, quality and regulatory compliance goals are met. Interfaces with research and development and/or new product development to integrate new products or processes into the existing sterilisation processes

Responsibilities:

  • Initiates and completes technical activities leading to new or improved sterilisation processes to meet strategic goals and objectives of the company. Prepares reports and makes presentations to communicate findings
  • Incorporates business policies and procedures into task completion. Understands the business needs of the company, and has a thorough knowledge of the customer and clinical needs of our business. Understands the business cycle and foresight of emerging technologies trends
  • Understands the regulatory requirements pertaining to the job and ensures sterilisation processes meet them
  • Cultivates internal and external network of resources to complete tasks. Serves as a resource in the selection orientation and training of new engineers and employees. May lead a project team, determining goals and objectives for the projects. Mentors employees by sharing technical expertise and providing feedback and guidance
  • Interacts cross functionally and with internal and external customers, in particular, developing good relations with contract sterilisation facilities
  • Ensure there is sufficient backup capacity in place for sterilisation processes

Minimum Qualifications and Experience:

  • Experience/Education
  • National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline
  • 2+ years of related work experience or an equivalent combination of education and work experience
  • Technical/Business Knowledge (Job Skills)
  • Wide application of technical principles, practices and procedures.
  • Strong understanding of business unit functions and cross group dependencies/ relationships.
  • Will perform this job in a quality system environment. Failure to adequately perform tasks can result in non-compliance with governmental regulations.
  • Cognitive Skills
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Has a sound knowledge of various technical alternatives and their impact.
  • Influence/Leadership
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.
  • Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel.
  • May lead a project team.
  • Participates in determining goals and objectives for projects.
  • Influences middle management on technical or business solutions.
  • May interact with vendors.
  • Planning/Organisation
  • Plans and organises non-routine tasks with approval.
  • Initiates or maintains work schedule.
  • Establishes priorities of work assignments.
  • Decision Making/Impact
  • Exercises judgement in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
  • Supervision Received
  • Works under only general direction.
  • Independently determines and develops approach to solutions.
  • Work is reviewed upon completion for adequacy in meeting objectives.
  • Supervision Provided
  • May provide work direction and guidance to exempt and/or skilled non-exempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.

QA Validation Specialist - Dublin

Responsibilities:

  • Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition.
  • Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.
  • Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
  • QA support for implementation of Manufacturing Execution System (MES) computer system validation deliverables.
  • Review and approval of engineering functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
  • Authoring, review and approval of QA-related procedures.
  • Oversee the effective documentation and tracking of quality management system activities including deviations and change controls and CAPA.
  • Review and approve Validation protocols as required. (Examples include cleaning, process, method validation).
  • Support the vendor quality management programme.
  • Participate in regulatory inspections as required.
  • Develop and report quality metrics.
  • Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
  • Represents Quality Assurance to guide various projects and technical meetings, as needed.
  • Responsible for documenting and reporting compliance issues to management.
  • Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.

Minimum Qualifications and Experience:

  • B.Sc. in science/pharmacy with a minimum of 5 years’ experience in cGMP Quality environment to include biopharmaceutical experience.
  • Min 5 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment. (BDS experience is essential).
  • Must have strong process knowledge to include upstream and/or downstream processing.
  • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Excellent communication & presentation skills are essential.
  • Excellent time management organizational skills along with a proven ability to multi-task.
  • Knowledge of automation and IT systems a distinct advantage.

Formulation Scientist – Waterford City

Responsibilities:

  • Project Planning:
    • Together with the Formulation Development Manager and Formulation Development Team Lead, actively plan on-going formulation development requirements; ensuring major milestone targets for each project are visible to all team members and key stakeholders to achieve on time market entry.
    • Together with the Formulation Development Manager and Formulation Development Team Lead, determine tasks required to deliver each project milestone by breaking them down into tasks; identify equipment, materials and people needed.
    • Proactively build effective working relationships with Core Team and Functional Members.
  • Compliance:
    • To ensure that work carried out is in compliance with required standards conforming to company, cGxP, SOPs, regulatory regulations & guidelines, Health, safety and environmental guidelines.
    • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Highlight opportunities for system optimisation to team members.
    • To support all on-going formulation and regulatory functions & requirements.
    • To complete all documentation correctly in order to achieve a high level of customer satisfaction and compliance to GMP.
    • To prepare reports and submission documentation in support of licence applications to various regulatory authorities.
    • To perform additional team tasks as agreed to support effective running of the Business
  • Health & Safety
    • Ensure requirements of company Safety Statement are implemented
    • Continuously promote a positive safety culture by leading by example
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
    • Report any defects

Minimum Qualifications and Experience:

    • Qualified to a minimum of honours degree level in Pharmaceutical science or related discipline.
    • At least five years’ experience working in a formulation development, process development, manufacturing or related technical environment.
    • Pre-formulation experience, including drug characterisation and ingredients selection.
    • Formulation studies, considering such factors as particle size, polymorphism, pH and solubility, as all can influence bioavailability and drug activity.
    • Process optimisation and scale up experience are essential
    • Analytical/ laboratory experience would be advantageous.
    • Have demonstrated effective research skills, including the critical review of the scientific literature.
    • Knowledge of all drug product manufacturing processes is essential.
    • Fill Finish and Dry Powder Inhalation (DPI) experience is advantageous.

QC Chemist – Waterford City

Description:

Contribute to the continued success of our client’s QC department by providing analytical services to support our diverse manufacturing operations. Engage with their Continuous Improvement programme to share your ideas and experience to further optimise the laboratory function. Comply with all regulatory and safety guidelines to protect yourself, your colleagues and patients.

Responsibilities:

  • Provide analytical chemistry services and support to Site
  • Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. In particular, close contact maintained with Quality Assurance Production, Engineering and Planners
  • Maintain, update and issue chemical methods, specifications and SOP’s in compliance to pharmacopoeial and regulatory requirements
  • Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOP’s and updates
  • Trend such results, record on COA’s where required and complete OOS’s investigations on a timely basis
  • Support new product introduction projects

Skills/Qualifications:

  • Degree in Science (Chemistry or Biochemistry preferred). Post-graduate studies as appropriate to augment primary degree
  • Operational experience of quality laboratories in a fast moving manufacturing environment
  • Detailed knowledge of quality management systems, pharmaceutical manufacturing operations, requirements for cGLP, pharmacopoeial methods and stability
  • Understand relevant quality/compliance regulations
  • Can manage projects to plan/budget

QA Officer – Waterford City

Purpose:

The main purpose of the role is to support manufacturing areas with QA support including but not limited to the following:

  1. Real time in situ batch documentation review

  2. Real time assessment of manufacturing events from a QA perspective.

  3. Provide clearance to precede instructions in manufacturing following unplanned events. 

Minimum Qualifications and Experience:

  • A third level degree incorporating Quality Assurance/ Management.
  • Have minimum 2 years relevant experience in a Pharma role / GMP related role.
  • Experience with desktop and internet-based software applications (e.g. electronic document management system, MRP system) an advantage but not essential.
  • Excellent communication and presentation skills
  • Focus on quality and detail
  • Careful planning to achieve accurate and timely result
  • Ability to define and manage own tasks and schedules
  • Experience performing and assessing risk/impact assessment an advantage

Senior Infrastructure Engineer - Waterford City

Description:

The Senior IT Infrastructure Engineer will support the Infrastructure/DBA Lead for all site IT Infrastructure, including Servers, PCs, Data Storage, Network infrastructure, security, business continuity and applications.

Responsibilities:

  • Responsible, as part of a team, for providing support to a very large number computing devices and users within the Waterford Facility
  • Will be required to provide out of hours support on a Rota basis to the Plant for critical areas – Minimizing Downtime.
  • Expert in enterprise systems and software such as SCCM, GPO, AD, DNS, DHCP, Bitlocker etc
  • Proficiency in system admin scripting
  • Capable of design, configure and support of computer Infrastructure including Network, SAN, NAS, Servers, PCs, Laptops, Centralized Print System and general hardware
  • In-depth knowledge of windows patching and WSUS
  • In-depth knowledge of backup systems such as Data Protector and Veeam
  • Responsibility for Backup, Restore and Disaster Recovery strategies.
  • Responsibility for VMWare solution – configuration & support.
  • Responsibility for various Infrastructure projects.
  • Responsibility for Computer & Comms rooms – fiber, cabling, power, cooling & general facilities
  • Good understanding of cisco switches and access points
  • Installation and support of various software applications.
  • Liaise with vendors on technical projects, installations and error resolution
  • Knowledge of enterprise systems such as Office365, desktop backups, web proxy, firewall
  • In-depth knowledge of mobile devices such as phones and tablets
  • In-depth knowledge of server storage solutions
  • Be able to juggle a mix of 70% daily tasks and 30% infrastructure projects
  • Familiarity with administering oracle databases advantageous

Skills/Qualifications:

  • Third level Qualification in Computer Science or similar
  • Professional Project Management Certified is preferred
  • 3 years experience in a similar role
  • Previous experience in regulated manufacturing environment advantageous
  • Familiarity with administering oracle databases is desirable

BDS Manufacturing Technologist - Dublin

Responsibilities:

  • Manufacturing Technologists are responsible for Manufacturing Support to the BDS operations at College Park, Dublin. They help to build and sustain employee engagement by creating a culture of open, efficient execution and an environment in which individuals and teams can excel and continuously improve.
  • The level 3 manufacturing technologist is a senior role, which requires significant subject matter expertise and provides technical leadership, leading complex projects relating to improvements and investigations within the BDS operations function.
  • Leader and provider of expert technical and documentation support to investigations, CAPA’s, change controls, training and improvement projects ensure the manufacture of bulk drug substance is performed in a safe, compliant, cost effective manner meeting the regulatory requirements defined in relevant health authority submissions, cGMPs and local Health and Safety requirements.
  • During the start-up project and routine new product introductions, the Manufacturing Support team provide end user operations requirements input into design, commissioning and validation of equipment, automation and processes as part of multi-function project teams.
  • The Manufacturing Support team takes a lead role developing Operations procedures, batch records (electronic or paper as required), other documentation and provide technical training to the Operations teams.
  • Manufacturing Technologists take an active role in setting up work practices and procedures that minimize human error, and work with operations continuous improvement teams to remove sources of error.
  • Manufacturing Technologists successfully lead teams to deliver all project requirements associated with cost, time and functionality, ensuring that all KPI targets are achieved.
  • The Manufacturing Support team Develop and maintain strong and effective relationships with partners at College Park including Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources and Finance. They lead and contribute to best practice sharing with manufacturing and technical colleagues at other client facilities and across the industry.

Minimum Qualifications and Experience:

  • Undergraduate degree in science or engineering or equivalent is required
  • A minimum of 8 years’ experience in Manufacturing Operations, Technical Support or Equipment Engineering in a biopharmaceutical company or closely aligned industry
  • Extensive knowledge of biological manufacturing processes
  • Significant experience with leading projects in areas such as media prep, buffer prep, sterile filtration, upstream and downstream unit operations. Experience of formulation, aseptic and sterile manufacturing, including, autoclaves, sterile filtration, Vial and Syringe packaging would be an added advantage
  • Experience of capacity expansion and new product introduction project work is essential and experience of a green field start-up is desirable
  • Experience in investigating complex manufacturing investigations, CAPA’s and Change Controls
  • Good knowledge of GMP/HPRA/FDA regulatory requirements and current Health and Safety Regulations legislation
  • Well-developed analytical, numerical and computer skills and the ability to combine hands-on activities with theoretical knowledge and expertise
  • Good Presenting and Training Skills
  • Good Technical writing skills
  • Excellent communications and decision-making skills
  • Min Green Belt in Lean six sigma
  • Proven ability to work well as part of a team & on own with minimum supervision
  • Proven leadership skills
  • Other duties as required

Senior Quality Engineer (R&D) – Waterford City

Description:

Ensure that all required Quality systems are implemented and effectively operating in the R&D development Lab. Ensure that all R&D project activities are carried out in compliance with the requirements of Quality Systems, FDA and other regulatory agencies up to and including Process validation. Provide oversight for Design Management of contact lenses – from a Quality System and technical perspective. Provide Quality Support to Manufacturing Plant as required.

Responsibilities:

  • Support Development Lab activities from a quality systems perspective
  • Implement and effectively maintain compliance with regional directives and procedures across R&D activities
  • Review and approve all protocols and reports for R&D equipment qualifications
  • Review and approve all protocols and reports for the manufacture of Clinical Trial Materials
  • Review all batch history records for clinical trial materials prior to issuing QA Release memo
  • Provide Regional Quality support for all Design Control activities
  • Drive and oversee all Risk Management activities for new product development
  • Complete and provide Risk Management and Complaint data updates to Annual Product Quality
  • Reviews and for revision of Design Risk Analysis and Clinical Evaluation Reports
  • Review and approve all Process Validation protocols and reports for new products

Scope of Position:

  • Ensuring that Quality systems are effectively implemented and maintained in Waterford R&D
  • Ensuring Compliance with quality standards and GMP requirements for all product/ process development activities in the R&D program of work through participation in R&D process development teams and approval of protocols.
  • Regional Quality support for all Contact Lens development projects in Waterford from inception to successful technology transfer / scale-up.
  • Risk management activities through development and product lifecycle.

Minimum Qualifications and Experience:

  • Bachelor degree in Science or Engineering
  • Certified training in Quality Systems Requirements of FDA and ISO-13485
  • Certified training in Auditing of Quality Systems
  • Documented training in all relevant company Directive and Procedures
  • 5+ years relevant experience in a similar industry

Senior Quality Systems Engineer (MDR Implementation) – Waterford City

Description:

The primary function of the Senior Quality Systems Engineer is to provide support to the MDR team and ensure all required objectives associated with 2017/745 (MDR) are implemented in the lens manufacturing plant. This role will report to the Quality Systems Manager.

Responsibilities:

  • Assist with the execution of Medical Device Regulation in the manufacturing plant as identified by the MDR Project team
  • Implement any Plant Quality systems changes as identified by the MDR Project team
  • Implement plant Change management activities for the implementation of MDR QMS

Requirements

  • Provide Supplier Quality support to any supplier changes / material changes that will occur due to MDR
  • Support new MDR Requirements around post market Surveillance
  • Work closely with the plant ensuring clear communication of any new MDR requirements
  • Support risk management, risk analysis and health hazard analysis associated with post market information.
  • Additional requirements of the job will be specified by the Quality Systems Manager

Minimum Qualifications and Experience:

  • 3rd level Qualification in Quality / Science / Engineering with a minimum of 5 years work experience in a Quality Systems Engineering role
  • Experience working with an ISO13485:2016 compliant quality system essential
  • Operational Excellence Training advantageous
  • Self-directed and results driven team player. Ability to work on own initiative, to deadlines, while also capable of working as part of a multi discipline team
  • Strong problem-solving skills and ability to handle multiple tasks in a fast paced environment
  • Excellent interpersonal and communication skills, both written and oral with the ability to work effectively with staff at all levels of the organization
  • Excellent organisational skills, ability to take on and drive a project

Project Co-Ordinator (Senior Engineer) – Waterford City

Description:

This engineer will lead product development & process development activities, writing protocols, data gathering and analysis. The Candidate will be skilled in reporting and presentation of data analysis. Candidates will lead data analysis and provide recommendations on trends, correlation, response variables, DOE’s etc. in an effort to better understand process interdependencies. The candidate will co-ordinate requirement setting to define automation requirements. They will also lead process capability finalization for manufacturing and conduct complete transfer of mature processed to manufacturing. The candidate will be interfacing with and leading internal cross functional teams while working on the programs.

Responsibilities:

  • Lead new produce/process validation
  • Design, execute and analyze experiments. Teach others to use analytical analysis tools and drive data driven decision making
  • Lead process optimization
  • Develop and support new manufacturing processes and technologies
  • Lead existing manufacturing processes, quality improvements and cost reductions
  • Ensure product quality and all tasks are in accordance with established SOPs, GMPs,
  • Divisional Specifications and EHS standards
  • Train manufacturing and junior personnel

Minimum Qualifications and Experience:

  • Degree in Scientific or Engineering Discipline
  • Special Skills: Computer Literacy with skills in Microsoft Excel, Word and PowerPoint, plus Minitab, JMP (or equivalent software)
  • Expertise in Statistical Analysis including experience of DOE and SPC. Communication, organization, report writing and presentation skills a must
  • Must be able to develop working relationships with various internal core Competencies and lead team members
  • Specialized Training: Six Sigma Black Belt and DFSS experience preferred
  • Minitab/JMP Statistical Software preferred
  • 5 years experience in a similar industry

Instrumentation Specialist – Waterford City

Description:

To provide specialised technical support to the analytical functions to support all on-going Development, QC and Stability functions. This includes, but is not limited to, the following areas:

• Equipment Maintenance

• Calibration

• Laboratory Computerised Systems

Responsibilities:

• To perform instrument calibrations including balance monthly calibrations, HPLC, UV, FT-IR, Conductivity Meter and Dissolution baths etc.

• To organise and sign off on external PM and calibrations.

• To maintain equipment calibration and maintenance schedules.

• To perform Instrument and method trouble shooting as required.

• Attends meetings within the company to discuss changes and modifications in laboratory equipment.

• To ensure that all work carried out is in compliance with the required standards, conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.

• To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.

• To perform additional team tasks as agreed to support effective running of the Business.

Health and Safety

  • To perform Safety Tasks – New Material Assessment Risk Assessments etc
  • Implement Safety requirements as per site documentation including SOPs, Safety Statement and COPs
  • Reports any Defects
  • If Unsure about safety requirements – ask

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level
  • At least five years’ experience working in a related technical environment is preferable but not essential
  • Troubleshooting of Analytical Equipment
  • Operation of HPLC, UV, FT-IR, Dissolution Bath etc.
  • Knowledge of laboratory computerised systems e.g. Empower
  • Computer skills and Project Management