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

Principal Scientist - Lyophilisation - Waterford City

Purpose:

The role is to support the the design and scale-up of lyophilisation processes suitable for clinical production, including cycle optimization, robustness studies, and technology transfer.  Candidates should have biotechnology educational attainments, a minimum of five years’ experience within the pharmaceutical industry, preferably in a Biopharma role with significant exposure to Lyophilisation & cycle development, and have ideally worked within an aseptic fill finish environment.  

Responsibilities

  • Advise on lyophilisation cycle development, optimization, scale up and Technology Transfer of finished products using state of the art techniques
  • Design and execute accelerated stability testing plans that demonstrate suitability of Lyophilised formulations
  • Complete required batch documentation records with accuracy and legibility
  • Ensure product quality by performing in-process checks, complying with current good manufacturing practices
  • Track and report deviations to a process, initiating quality improvements and participating on quality improvement projects as required.
  • Act as R&D liaison between relevant Managers, Q A, Research, Tech Services, Engineers and Maintenance personnel in all matters regarding freeze drying
  • Participate on manufacturing project teams to assist with cycle development through collaboration with R&D.
  • Review work scope, rationale, approvals, changes to appropriate equipment/systems and re-qualification activities
  • Assist in the training of sterile operators or cross-training in other areas.
  • Troubleshoot and perform adjustments on equipment as required.
  • Ensure that all work is carried out in compliance with the required standards to conform to company, cGxP, health and safety, environmental and regulatory requirements.

Qualifications:

  • You MUST be passionate about Lyophilisation and Biopharma
  • An honours degree in Science/Biotechnology (or a related discipline)
  • You MUST have at least 5+ years’ experience
  • Significant exposure to Lyophilisation & cycle development
  • Ideally have worked within an aseptic fill finish environment
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.

Technical Services Analytical Team Lead - Waterford City

Description:

Currently seeking a Technical Services Analytical Team Lead. We are looking for someone who can prioritise and coordinate the execution of Technical Services Analytical activities in line with department and company requirements.

Responsibilities:

  • Assist the Technical Services Manager in achieving company goals
  • Day to day scheduling of laboratory activities
  • Working in real time by ensuring the laboratory work in progress is kept to a minimum.
  • Timely close out of deviations and/or investigations.
  • Assist with the timely completion of data reviewing as required.
  • To identify training requirements and training of Chemists and organize training as required.
  • To calibrate and check calibrations of laboratory instrumentation as required.
  • Take responsibility for issues as they arise and elevating them where necessary.
  • Timely and complete handover of documentation and work in progress.
  • Reporting on results via correct documentation in real time.
  • To draft procedures, protocols, reports and company documentation as required.
  • 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.
  • Adhere to all good housekeeping practices
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement
  • Representing the Technical Services department at internal meetings and communications with customers.

Minimum Qualifications and Experience:

  • Relevant third level qualification
  • At least 5 years previous relevant experience

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.

Quality Assurance Specialist - Dublin

Responsibilities:

  • Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness for biologics facility
  • Review and approval technical support documentation. (Examples include cleaning, process, method validation, risk assessments)
  • Review and approval of manufacturing batch records
  • Provide quality support for implementation of new product on SAP
  • Review and approval of functional area documentation
  • Authoring, review and approval of QA-related procedures
  • Oversee the effective documentation and tracking of quality management system activities including deviations and change controls, CAPA
  • Any other duties as required by management

Minimum Qualifications and Experience:

  • B.Sc. in science/engineering with a minimum of 4 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
  • Min 4 years QA experience in a pharmaceutical manufacturing environment
  • 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.

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 – 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.

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

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).

Specialist Technical Services (Process Validation Specialist) - Dublin

Description:

The Process Validation Specialist has primary responsibility in supporting the successful start-up and process validation (PPQ) of cGMP manufactured biological bulk drug substances (BDS) as part of the Technical Services Team at the facility in Dublin. The Process Validation Specialist will support all process validation (PPQ) activities, with particular focus on prospective Process validation (PPQ) and associated supporting concurrent validation protocol, and process monitoring programs in support of OPV/CPV. The Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility start-up and process qualification (PPQ). The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, delivery of Process Validation (PPQ), Process Monitoring, Risk Assessments (using QRM tools), and building strategies / SME capability

Responsibilities:

  • To provide process expertise in the area of process validation, including process performance qualification (PPQ) and continued process verification (CPV).
  • Working knowledge of typical drug substance unit operations, including upstream cell expansions and bioreactors, harvest operations and downstream chromatography and filtration unit operations and functional purpose, cause and effect, in-process tests, and mass balance principles.
  • To author and review process validation documentation (protocols/reports), including validation strategies, risk assessments, protocols and reports, including process validation documentation & strategy documents.
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements.
  • To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
  • May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution as required.
  • To provide on the floor support for troubleshooting processing issues and to lead technical assessment of investigations into process deviations and resolution with CAPAs.
  • Lead any key process changes using change control management system.
  • Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
  • Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations.
  • To author and review and assist in documents that input into IND, BLA and other technical documents for regulatory agency submissions.

Minimum Qualifications and Experience:

  • Minimum requirement of B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering (5+ years’ experience), or PhD (3 years’ experience).
  • Minimum 5+ years’ experience in Technical Services / Process Development / Manufacturing Support / Research with experience in leading process validation projects (PPQ) in a biological bulk drug substance or equivalent manufacturing processes.
  • Experience in developing validation strategies, as well as writing validation protocols and reports, (with multi product focus).
  • Technical and operational knowledge of multiple unit operations in typical BDS unit operations
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings.
  • Ability to present and defend technical and scientific approaches in both written and verbal form.
  • Ability to drive for results independently and adapt to rapidly changing priorities
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing, including process validation, OPV/CPV.
  • Technical writing competency.
  • Detail orientated.
  • Experience of Cleaning Validation/verification, or supporting studies of same would be advantageous.
  • Experience of authoring CMC sections of regulatory submissions would be advantageous.
  • Capable of presentation of overview/playbooks to support internal and Regulatory audits.
  • Experience of Technology Transfer activities is advantageous.
  • Knowledge or experience of start-up or systems would be ideal.

Bioprocess Technicians – Dublin

Responsibilities:

  • All bioprocess technicians will be trained and competent to independently perform all core production tasks in the areas of cell culture, media preparation, purification, buffer preparation and all ancillary tasks such as equipment preparation.
  • Role requires people leadership skills and the ability to frequently act as designee for the shift lead (manager level) and to act as decision maker across multiple interdependent functions including operations and maintenance.
  • The level 3 bioprocess technician will also develop and demonstrate individual specialisms as subject matter expert across multiple process technologies.
  • Adept at gathering and analysing process and operational performance data and leading operational process improvements.
  • Display technical leadership and specialisation by acting as ‘Champion’ and leading improvement initiatives across shifts and functions.
  • Responsible for execution of all tasks associated with the preparation for and production of products in cGMP environment ensuring full attention to detail and excellent documentation skills.
  • Assist in maintaining a safe, cGMP compliant work environment at all times
  • Responsible for completion of tasks according to SOPs and batch records (paper and electronic).
  • Perform initial troubleshooting of issues identified during routine operations.
  • Assist with the investigation of and operations deviations through the Trackwise system, engaging with all relevant personnel and functions as appropriate.
  • Assist where necessary with the training of colleagues in SOPs, process execution and equipment operation.
  • Provide input into the creation and maintenance of area SOPs and batch records.
  • Seek and implement opportunities for Continuous Improvement.
  • Use Lean Tools as part of daily operations (Standard Work, 5S, Method 1, 2 etc.) to optimize efficiency and drive the culture of Continuous Improvement and Right First Time execution.
  • Where necessary assist in any Facility and Equipment start up and Validation activities. Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.
  • Shift working is required. The shift pattern may be varied according to business requirements and will typically require weekend working and periodic rotation between day and night shifts.
  • Any other duties as required by management.

Skills/Qualifications:

  • Proven technical leadership and complex decision making abilities in a biotech operating environment
  • Must be able to work within and adapt to complex electronic systems such process automation, SAP and Trackwise investigation system
  • Must have in-depth knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOPs
  • Must be familiar with biopharmaceutical equipment and systems such as bioreactors, centrifuges, autoclaves / glass washers, media/buffer systems, and purification systems
  • Knowledgeable of current Good Manufacturing Practices (cGMPs) and regulatory requirements
  • Must possess strong verbal and written communication skills
  • Requires 8+ years’ experience in a cGMP biotech manufacturing environment
  • BA/BSc in a scientific discipline or equivalent experience preferred

QA Manufacturing Engineer - Waterford City

Description:

The QA Engineer is instrumental in providing support to the Manufacturing QA Manager to ensure that the manufacturing operation produces product that meets specification within a manufacturing environment that complies with all relevant standards. This role is a shift position.

Responsibilities:

  • Deliver a number of projects related to improve QMS.
  • GMP inspection process
  • 5S Deep cleaning process
  • Develop process meetings to support daily QA activities
  • Managing the NC metric on a day to day basis
  • Standardisation/Lean the management of NCs. (stewardship)
  • These project would be delivered subsequent to demonstrating good process knowledge in each of the Areas.
  • Also supporting the day to day management of the Lens manufacturing process involving Non-Conformances, CAPAs, QCRs and change requests.
  • The Manufacturing Quality Manager will specify additional requirements of the job.

Key cGMP Responsibilities:

  • Always Follow Standard Operating Procedures
  • Have awareness to applicable standards
  • Awareness to the QMS requirements.
  • Understand and follow Personal Hygiene Rules as defined in the GMP
  • Training Programme and notify area supervision of any health conditions, which may affect the quality of product.
  • Always Maintain the work area in a clean and tidy manner

Skills/Qualifications:

  • Minimum 3 yrs experience in a regulated pharma/medical device environment
  • Full understanding of the requirements of the regulatory standards
  • Third level qualification, ideally in Engineering or Science
  • Strong analytical/statistical skills with good knowledge of process control systems
  • Knowledge of Six Sigma and Lean tools
  • Self motivated with ability to handle multiple priorities
  • Decisive, good communicators, self-motivated, have record of achievement and be a good team member.
  • MS Office experience
  • Project Management Experience would be very helpful in this role

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

Microbiology Analyst - Waterford City

Responsibilities:

  • Analysis of raw material, in process material and finished products as required
  • Sampling of materials, utilities and environment
  • Analysis of utilities and services i.e. water, air, environmental
  • Participate in method transfer, method development and validation s as required
  • Ensure that all testing equipment is cleaned, set-up and operated according to Standard Operating Procedures
  • Perform on-line machine adjustment and trouble-shooting where necessary
  • Review and assess results and action appropriately e.g. OOS, material Status, deviations, alarms etc
  • Managing consumables supply within the laboratory
  • Compilation of data and reports as appropriate for quality activities
  • Completion of documentation and tasks in compliance with GMP and good scientific principles
  • Maintains procedures for Quality Control activities such as SOP’s, specifications, test methods, etc
  • Carry out all in compliance to company Safety & Environmental Standard Operating Procedures
  • Participate in team based project work and plant-wide initiatives to improve the GMP compliance and financial performance of the Pharma area
  • Report any deviation from quality standards/specifications or any extraordinary occurrences to relevant manager
  • Other duties as assigned by area supervision/management

Skills/Qualifications:

  • Qualification in science discipline at primary degree or diploma level. The Qualification must have a high microbiological content
  • Experience in endotoxin analysis, bioburden analysis, and sterility would be an advantage. Basic techniques e.g. culture transfer, growth promotion are required
  • Experience in Method validation and method transfer would be an advantage
  • Experience of scientific report writing including such documents as SOP’s, protocols, deviations, reports etc
  • A min of 2 years’ experience in a regulated pharmaceutical environment
  • Familiarity with FDA and EU requirements for finished pharmaceuticals is preferred
  • Understanding of pharmacopeia requirements for pharmaceuticals

Equipment Compliance Analyst - Ringaskiddy

Description:

The primary purpose of this role is to serve as a member of the Lab Support group within the client environment to support their technical and analytical support tasks, to work to the highest standards in terms of quality and professionalism.

Responsibilities:

  • Coordinate equipment qualification processes, including writing and progressing associated Change Control. Appropriately document all equipment management tasks in accordance with site procedures and ensure accurate records management
  • Coordinate and assist with the introduction of new equipment to the lab and the retirement of old equipment as required, administration of TAG numbers and SAP updates
  • Assist with Change Controls and document updates related to equipment management & lab support activities as needed
  • Coordinating & responding to ad-hoc requests for information and/or assistance relating to Empower administration queries
  • Organise and assist as necessary with vendor or internal equipment calibrations
  • Coordinating & performing routine maintenance on and cleaning of laboratory equipment
  • Coordinate, review and drive equipment management tasks carried out by others along with review of associated records
  • Coordinating & responding to ad-hoc requests for information and/or assistance relating to equipment management
  • Writing of SOPs related to area of work
  • Training, mentoring and guidance of the more junior team members to ensure understanding and competence in all tasks
  • Dealing with client requests and liaising with the Team Leader in terms of resources, continuous improvement and ensuring continuity of service to the client
  • Coordinate, perform and review the shipment of samples externally for analysis
  • Assisting the Team Leader in terms of scheduling, training plans, execution of training and ensuring routine tasks are completed on time, right first time
  • Maintaining all documentation and systems related to their work in collaboration with the client personnel and their suppliers
  • Participating in laboratory investigations as requested
  • Generation of certain quality and business related metrics
  • Keeping their training records up to date and initiating training where possible when free from work
  • Adhering to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies
  • Ensure that all documentation is carried out on time, accurately and legibly
  • Ensuring any quality or productivity issues within the team are investigated and dealt with appropriately, initiating CAPA as soon as appropriate
  • To be constantly aware of the client’s requirements and strive to meet or exceed those requirements he client process and deliverables
  • To identify and communicate to PSS Management and the client areas for improvement or optimisation in order to improve efficiencies and provide a cost effective service.Actively participate in Lean and productivity improvement initiatives. Focus on continuous improvement and ability to propose and implement change
  • As with all members of staff this person is responsible for ensuring that the client requirements are fully met and in so doing will be flexible to work in any area of the business as is required

Skills/Qualifications:

  • At least 3 years GMP experience in a laboratory or e-system support environment is preferred
  • Knowledge of and direct experience with laboratory e-systems (E.g. Empower 3) a distinct advantage
  • Change control (especially utilising Trackwise) and equipment qualification experience preferred
  • Good team player
  • Good communication skills both internally and externally
  • Accuracy, attention to detail
  • Good organisation of work space and time management
  • Process improvement
  • Please note that occasional weekend work would be required for this role

Pharmaceutical Chemistry Analyst Level 3 - Waterford

Description:

The purpose of this job is to review scientific test procedures used on client samples ensuring that accurate results have been produced. This person will also work to develop any ancillary procedures associated with the processes used; ensuring customer samples are completed within their required specifications.

Responsibilities:

  • Responsible for reviewing data to the relevant regulatory standard, analytical procedures and appropriate documentation.
  • Responsible for the review of specific technological projects and writing up the results of these projects accurately, confidentially and on time for the clients.
  • Data Reviewers are permitted to sign all technical documents within the company once their training in this task is successfully completed. This includes laboratory reports, SOPs, protocols, investigation reports and any other documentation issued.
  • This person will perform analytical testing when not engaged in Data Review activities.
  • This person will ensure that all documentation is completed on time, accurately and legibly.
  • Responsible for updating any relevant documentation as required.
  • Responsible for handling any customer related queries where necessary and liaising with their team to problem solve these queries if needed.
  • To keep their training records up to date and to initiate training as per their training plan where possible when free from work
  • To adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.
  • To ensure that customers’ requirements are fully met and in so doing be flexible to work in any area of the business as is required.
  • To identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement.

Skills/Qualifications:

  • A degree or diploma in chemistry or a related discipline is desirable
  • At least 28 months experience in a GMP laboratory
  • Good team player, organised, accurate, have strong documentation skills
  • Passionate about quality and customer service
  • Good communication skills both internally and externally

QC Microbiology Analyst - Dublin

Description:

The QC Microbiology Analyst will support the Bulk Drug Facility in Dublin with emphasis on microbiological testing such as Environmental Monitoring, Water, Gas and raw materials sampling and testing, Bioburden and Endotoxin, technical support with regard to method validation, regulatory updates and new technology.

Responsibilities:

  • Environmental and Facilities monitoring sampling and testing.
  • Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
  • Validation/Qualification of Microbiology test methods and test systems such as the Endotoxin test system and Identification system.
  • Represent the Microbiology department in internal and external audits where appropriate.
  • Close out of actions/ recommendations identified from both internal and external audits.
  • Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate
  • To maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory.
  • Perform technical review of data generated in laboratory, validation protocols and reports.
  • Provide Technical support to Manufacturing and Projects which the company undertakes through project participation, investigation, validation and testing activities and prepare Technical Reports as required.
  • To ensure all instruments/equipment are maintained in a calibrated and operational state.
  • To ensure a high standard of housekeeping and safety is maintained in the Laboratory.
  • Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
  • To keep management updated on issues arising within the laboratory.
  • Scheduling of testing, review and authorization of microbial data.
  • Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
  • To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs.
  • Any other duties as required by management.

Minimum Qualifications and Experience:

  • Degree in Microbiology or related science.
  • Minimum of 1 year experience in cGMP Quality environment.
  • Experience in testing of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
  • Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
  • Technical competency in Sterility Assurance, Aseptic filling and microbiology methods.
  • Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.
  • Problem solving and root cause analysis skills.
  • Organizational skills.
  • Planning/scheduling of own work and subordinates and ability to delegate tasks where appropriate.
  • Excellent written and oral communication skills.

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.

Production Manager (3 Shift Cycle) – Waterford City

Description:

A production manager is involved with the planning, coordination and control of manufacturing processes. They ensure that goods and services are produced efficiently and that the correct

amount is produced at the right cost and level of quality

Responsibilities:

  • Manage production and the introduction of new technology through team leadership
  • Conduct Standard work for managers. Monitor standard work for team leads and operators
  • Responsible for the production activities including, PPI, Yields, Downtime, Quality Metrics and the utilization of machinery & human resources
  • Initiate changes to work practices and procedures
  • Provide a high level of technical competence and leadership to the shift to ensure that operational issues are identified and managed to achieve challenging KPI’s and higher operational performance
  • Promotion of decision making at operative I technician level through effective development and fostering of a strong team working culture
  • Promote a quality culture and act to ensure compliance with all regulatory requirements including FDA and cGMP
  • Conduct and manage performance appraisals for operators and identify and implement appropriate training & development plans.
  • Execute communications within the unit and to other departments within the company
  • Plan and manage team members attendance, timekeeping
  • Establish and maintain high standards in relation to Environmental Health & Safety work practice
  • Maintain high standards in relation to Environmental Health & Safety work practices
  • Meet budgetary targets set in relation to output and spend
  • Ensure compliance with manufacturing SOPs, Gowning up and other PPE policies, hygiene and EHS procedures at all times
  • Participate fully in all GMP training programs as identified and complete all Training Records in an accurate and timely manner

Skills/Qualifications:

  • 3rd level qualification, preferably in a technical discipline
  • Previous supervisory management experience in a manufacturing environment complying with FDA, cGMP requirements is essential (unionized environments preferred)
  • Advanced leadership skills to build and motivate the process team by providing clear direction and facilitation
  • Knowledge of carton and 3.8ml operation essential
  • A successful track record in managing conflict resolution

QC Data Reviewer - Waterford City

Description

To support Product Development, Commercial Supply and Stability by ensuring all

components, raw materials and finished products are tested in accordance with cGxP.

Responsibilities:

  • To review raw data from testing of components/raw materials/finished products /stability in a timely & efficient manner.
  • To manage and control all raw data presented for review and file once completed.
  • To complete required release documentation including stability summary sheets.
  • Trending of API, finished product and stability testing.
  • Complete investigations in a timely and efficient manner where applicable.
  • Identify and action recommendations for improvements.
  • Implement 5S and Lean lab initiatives.
  • To support all other on-going laboratory functions & requirements.
  • 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.
  • To assist in the preparation for customer/ regulatory inspections.
  • Health & Safety
  • Implement safety requirements as per site documentation including SOPs, Safety, Statement and COPs
  • Report any defects
  • If unsure about safety requirements – ask

Skills/Qualifications:

  • Qualified to a minimum of degree level.
  • At least two years’ experience working in a related technical environment.
  • Analytical Test Methods – Creation and Review
  • Operation of HPLC
  • Operation of GC, FT/IR
  • Computer Skills/Excel etc.

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

Senior Biologics Technical Specialist – Ringaskiddy

Description

The primary purpose of this role is to support the Large Molecule API technical team to formulate characterisation plans to advance understanding of raw materials in manufacturing processes, design, execution and/or lead experiments in support of raw material qualifications

Responsibilities:

  • Collaborate closely with the Material Science group based in the client’s sister site in the US and guide pharmaceutical development teams on the selection of materials based on scientific, quality and regulatory criteria.
  • Collaborate with raw material suppliers within Ireland and Europe to establish effective control strategies based on understanding and importance of raw material in API manufacturing
  • Contribute towards developing raw material specifications, e.g., cell culture media, chromatography resins and excipients
  • Perform Bill of Materials Assessment for new materials introduced to the site and source alternative vendors and suppliers when needed
  • Support Analytical method transfers by coordinating testing with Europe based Analytical labs
  • Review and implement industry and regulatory requirements for raw materials, e.g., ICH guidance
  • Support raw material investigations and life cycle activities related to raw materials including leading and/or participating in root cause analyses
  • Support supplier audits as required
  • Identify and coordinate analytical characterisation with the internal and external labs and perform testing as applicable
  • Actively participate on cross-functional R&D and manufacturing teams to advance projects goals and deliverables related to raw materials
  • Participate in project and scientific meetings to share information, knowledge, ideas, and judgment to help establish valid scientific directions in product development or investigations
  • Ensure compliance with safety, GMP, quality and scientific principles
  • Perform other duties as agreed with the client and directed by the ELL Manager.
  • Develop subject matter expertise on assigned analytical techniques.
  • Independently write/revise SOP’s or other official documentation and technical reports, when required.
  • Execute independently assigned projects.
  • Train/Coach other personnel.

Skills/Qualifications:

  • A BSc in a Science subject, Materials Science, Chemistry, Engineering or a related field, with at least 9 years of experience or a MSc in in a Science subject, Materials Science, Chemistry, Engineering or a related field with at least 6 years of experience or Ph.D. with at least 2 years of post-doctoral experience is essential
  • Proficiency in functional characterisation of cell culture media including cell culture performance evaluation using stationary, shake flask, automated cell culture systems, and/or bioreactors is required
  • Demonstrated proficiency in the analytical characterization of cell culture media and materials utilized in upstream processes and downstream processes is preferred
  • Experience in qualification of cell culture media and raw materials and is strongly preferred
  • Demonstrated competency and experience in development and management of raw materials specifications including compendia testing is an advantage
  • Demonstrated competency and experience in use of project management and database tools (e.g., MS Project)
  • Microsoft office proficiency in Excel, Word, PowerPoint are required
  • Experience with lean and/or six sigma methodologies and tools is preferred
  • Ability to quickly learn new processes.
  • Ability to communicate clearly and to form strong working relationships with colleagues.
  • Willing to operate in a flexible manner and be able to switch priorities at short notice.
  • Organised, accurate, have strong documentation skills.
  • Passionate about quality and customer service.
  • Good communication skills both internally and externally.

Group Lead Technical Scientist - Ringaskiddy

Description:

The primary purpose of this role is to lead and manage an off-site Professional Staffing Services team of API lab support analysts and technical scientists to ensure that team is operating at the highest quality and productivity standards, have high morale and retention, and the agreed customer requirements are entirely satisfied and that customer expectations are met or exceeded through effective leadership and quality operational management.  This person will be the key point of contact for the client on a day-to-day basis.

Responsibilities:

  • Effectively coordinating and managing members of the PSS team so that productivity, quality, documentation, work schedules, safety and housekeeping is run at maximum efficiency.
  • Responsible for ensuring that the client gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards and GMP compliance.
  • Responsible for the development, coaching, motivation, and morale of team members through effective teambuilding and use of reward and recognitions systems celebrating team success.
  • Responsible for reviewing and approving all relevant documentation and technical data in a timely manner and ensuring that it communicated, documented, and filed accurately.
  • Responsible for ensuring that work is scheduled and cross training takes place so that the service levels agreed with the customer are achieved. Responsible for amending schedules as required.
  • Ensure that all analysts are trained and have completed training records for all activities and other training completed.
  • Responsible for carrying out performance appraisals with staff as part of the overall performance management programme within the organisation.
  • Responsible for continuous feedback to all members of their team on all items in relation to client or organisational requirements / changes.
  • Responsible for handling any customer related queries where necessary and liaising with their team and with personnel from other teams to problem solve these queries if needed.
  • Perform investigations, where required, for API Large Molecule Lab issues etc.
  • Perform other duties as designated by Laboratory Management.
  • Support early and late phase Technical Transfer activities through generation of protocols/reports, technical writing, execution of laboratory scale studies and participation in manufacturing operations and NPI initiatives.
  • Supporting early and late phase product development activities through generation of protocols/reports, execution of laboratory scale studies and participation in Lean Early Development initiatives as required.
  • Providing expertise to development teams on manufacturing facility design and capabilities, scale-up considerations and GMP operations. Partner with Project Teams to provide input, review and approval support for BLA submissions.
  • To interpret project plans and timelines for CMC projects and schedule work and experiments to meet these goals.
  • To assist in manufacturing investigations as required, in particular event, deviations and CAPAs, to help meet product release specifications and timelines.
  • To execute experimental plans and protocols to support product life-cycle improvements, process validation requirements, technical transfer projects and development activities as required.
  • To foster a culture of Lean and Continuous improvement within the department and with internal and external partners.

Skills/Qualifications:

  • A Bachelor Degree or Masters Qualification or PhD Qualification in Biotechnology, Biopharmaceutical sciences or relevant biological or life science is required.
  • At least 5 years of GMP industry experience
  • Excellent leadership skills and at least 3 years’ previous supervisory experience.
  • Analytical skills to troubleshoot laboratory issues are an asset.
  • Ability to quickly learn new processes.
  • Experience in aseptic techniques is required.
  • Ability to communicate clearly and to form strong working relationships with colleagues.
  • Willing to operate in a flexible manner and be able to switch priorities at short notice.
  • Organised, accurate, have strong documentation skills.
  • Passionate about quality and customer service.
  • Good communication skills both internally and externally.
  • Excellent attention to detail
  • Good communicator – easily communicate findings and recommendations to internal clients.

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

Manufacturing Engineer – Waterford City

Responsibilities:

  • Evaluates manufacturing processes by designing and conducting measurement programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
  • Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
  • Improves manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
  • Assures product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes.
  • Provides manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
  • Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
  • Provides manufacturing engineering information by answering questions and requests.
  • Maintains product and company reputation by complying with government regulations in conjunction with QA.
  • Completes design and development projects by training and guiding technicians.
  • Maintains professional and technical knowledge by attending educational workshops and seminars.
  • Contributes to team effort by accomplishing related results as needed.
  • Supports hand over of new projects and processed from NPI Team.
  • Drives cost and waste reduction program.
  • Proactively investigate, define, propose and deliver continuous improvements for processes, accompanied by the appropriate level of investment appraisal.
  • Be operationally aware of process waste and actively seek solutions to reduce their affect.
  • Preparation of action sheets for Existing Customer Changes (ECNs) and responsibility for ensuring all changes are implemented in a timely manner.
  • When assigned, become project lead on new process introduction projects including interaction with Customer and all internal departments within company.
  • Preparation of In- house Drawings and CAD support for Engineering team where applicable.
  • Ensure adherence to the Production System (Process SOPs, W,I’s)
  • Liaising with relevant departments to ensure that operational support is given and project goals are met.
  • Be operationally aware of process waste and actively seek solutions to reduce their affect.
  • The continuous assessment, appreciation and implementation (where possible) of the latest manufacturing practices to support the progress of the company.
  • Keep self up to date with relevant SOPs and work practices.
  • Work within all aspects of Health & Safety programme and adhere to company safety policies at all times.
  • Keep your skills current and be conversant with the latest developments in technologies and materials which are relevant to the Company’s business. Engage constructively with other functions within the Company to drive continuous improvement.
  • To take on other duties which the Company may assign you from time to time. These “other duties” will be agreed with management prior to any assignment.
  • To meet and/or exceed the Milestones and Goals agreed with the Company.

Project Engineer – Waterford City

Description:

Executes and delivers key strategic projects, which increase the capability and capacity of our client. Applies engineering skills applicable to medical devices manufacturing, for all aspects of project delivery from feasibility, through manufacturing start up and hand over to the operations team. Aligns the requirements of other functional groups such as EHS, QA, Manufacturing, Engineering, Supply Chain, Facilities/Maintenance, and Validation for an overall project delivery. Directly responsible for tracking project cost, schedule, targets and achievements.

Responsibilities:

  • Manage multiple small to medium medical device projects from concept through design for manufacture, commissioning and qualification.
  • Assist Supply chain in identification of suppliers and sub-contractors.
  • Apply sound engineering and project management principles, in the delivery of the project.
  • Interface with client representatives, and other functional groups such as EHS, QA, Manufacturing, Engineering, Supply Chain, Facilities/Maintenance, and Validation etc., to manage and coordinate the development of project deliverables.
  • Generate project plans, scopes of work, cost estimates and quotations.
  • Generate work instructions and action change notes.
  • Manage internal / external teams to meet project schedules.
  • Review and approve documentation including specifications and drawings.
  • Manage manufacturing, assembly, tooling/fixture design and commissioning & validation activities.
  • Review and/or approve commissioning and qualification protocols.
  • Provide qualification and troubleshooting support for equipment and processes.
  • Independently manage technical, engineering and compliance matters relating to the projections on engineering problems and methods.

Skills/Qualifications:

  • Minimum 3 years of relevant experience within a medical devices environment, will also
  • consider other similar regulated industries such as pharmaceuticals.
  • Minimum of Bachelors’ degree (Honors) in Engineering (Level 8) – 2:1 Minimum
  • Proficient in Oral & Written communication skills
  • Must be able to read, write and understand English
  • Proficient in MS Excel & MS Project
  • Commissioning & Validation Experience – Equipment & Process experience preferred
  • Proficiency in a CAD package such as Solid Works, or equivalent, preferred
  • Proficiency in a Statistical Analysis package such as Minitab, or equivalent, preferred
  • Proficiency in an MRP package such as SAP, preferred
  • Ability to work on own initiative and to challenging schedules
  • Organized and adaptable with a flexible approach to Project Engineering

Continuous Improvement Engineer – Waterford City

Description:

Continuous Improvement Engineers (CIE) provide support in areas of Continuous Improvement and facilitate individuals and teams by implementing change and improvements to processes throughout the organization. The CIE is responsible for training of other personnel on continuous improvement tools and assures the highest quality and least costly manufacturing processes are put in place when improvements are made. Improvement activities include but not limited to participation in, and leading of cross functional teams through, the execution of continuous improvement projects on processes and methods while focusing on customer satisfaction, quality, safety, and productivity using lean six sigma methodology and tools.

Responsibilities:

  • Act as a change agent in the organization by driving change and implementing continuous  improvement processes, while utilizing and improving existing methodologies
  • Promote lean manufacturing practices by educating the organization in the use of lean
  • principles
  • Utilize lean manufacturing tools (i.e. value stream mapping, Kaizen, 5S, Gemba walks, root cause problem solving) to identify and develop solutions that drive operational improvement
  • Actively participate in, and lead, cross functional teams through the execution of continuous improvement projects, of processes and methods, focused on customer satisfaction, quality, safety, and productivity using the Lean Six Sigma methodology and tools
  • Create and update work procedures, forms, and process flows based on projects
  • Track, monitor and report regularly on status of projects
  • Provide analytics to support the need for a change and the return on investment
  • Additional duties and responsibilities as assigned

Skills/Qualifications:

  • Third level qualification in manufacturing, industrial or electrical engineering or similar
  • 2 years’ experience working in an industrial environment.
  • Lean Six Sigma – green or yellow belt

Industry Awareness

  • Regulatory Compliance
  • Conduct Internal and Supplier Audits as required.
  • Maintain Quality Documentation in the assigned areas of responsibility e.g. Work Instructions, SOP’s flow charts.
  • Ensure that work areas and equipment are maintained in accordance with GMP standards.
  • Ensure that any maintenance and Health and Safety problems/issues are reported.
  • Maintain company Health and Safety standards including PPE (safety shoes, company uniform, safety glasses etc.).
  • Ensure compliance with company procedures at all times

Facilities Engineer – Waterford City

Description:

The Facilities engineer will provide engineering support and leadership to site capital projects enabling our client in the delivery of high-quality projects safely, on time and within budget. The implementation and development of innovative systems to build excellence in process and equipment development and installation is a key element of the role. The role will initially support and deliver on capital projects with the launch of our client’s packaging operation, however interfacing with key functions across the campus and supply chain will be a requirement to ensure the successful development of the role and to support and deliver on key business objectives.

Responsibilities:

Construction/Project Management

  • Execution and project management responsibility for the introduction and installation of the packaging process
  • Life cycle cost considered in designs for maximum long-term efficiency and reliability.
  • Execution and project management responsibility for the construction of the packaging facility from a facilities aspect, inclusive of air handling systems, chillers, and air compressors.
  • Life cycle cost considered in designs for maximum long-term efficiency and reliability.
  • Follow site procedures in Project Management best practice, including PM methodologies, design, documentation management and standards.
  • Ensure scope is understood, communicated and locked through appropriate charter for the project.
  • Highlight and mitigate risks as early as possible.
  • Manage budgets to ensure control is maintained at all times.
  • Direct PFMEA studies and lead Risk assessments effort for the overall process
  • Design, develop and source all relevant equipment, source tools, fixtures and specialist equipment as required for successful implementation and project delivery
  • Manage scope through approved change control for any changes.
  • Ensure the quality of all works completed is to the highest standards and on schedule.
  • Ensure all documentation is appropriately reviewed and signed off.
  • Coordinate and attend FAT’s as required.
  • Ensure validation methodology is clear and integrated into the project from URS onwards.
  • Ensure documentation, training and handover meet the customers’ expectations

Contractor Coordination

  • Ensure contracts are binding and clearly linked to project scope, schedule, budget and specific skill sets.
  • Develop relationships with contractors. Ensure they understand our business and are compliant to site procedures.
  • Day to day supervision and management of construction contractors

Reporting and Governance

  • Provide timely and accurate reporting on project activities
  • Report covering 1) Schedule, 2) Cost control, 3) Project scope and 4) Risks and mitigations, compiled at appropriate intervals.
  • All Project related information stored centrally.

Health, Safety and the Environment

  • Comply with legislative requirements for construction projects.
  • Ensure Safety Management is paramount in project delivery processes.
  • Comply at all times with Health, Safety and Environmental policy and procedure.
  • 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, cGLP, SOP’s, regulatory guidelines.
  • Take ownership for quality compliance in all activities you are responsible for.
  • Assume responsibility for process / equipment and facility qualification and put in place a schedule for re-qualification.

Minimum Qualifications and Experience:

  • Qualified to a minimum of Degree level in an Engineering discipline.
  • Ample previous experience in contractor supervision, particularly in a construction site environment.
  • Experience and knowledge of Pharma sector ‘clean’ and ‘black’ utilities and the qualification thereof.
  • Safe pass.
  • At least 3 years Project Management experience, preferably in the Pharma sector.

Packaging Engineer – Waterford City

Description:

The packaging engineer will provide Packaging Engineering support and leadership to site capital projects enabling our client in the delivery of high-quality projects safely, on time and within budget. The implementation and development of innovative systems to build excellence in process and equipment development and installation is a key element of the role. The role will interface with key functions across the campus and supply chain to ensure the successful development and launch of our client’s packaging operation.

Responsibilities:

Project Management

  • Execution and project management responsibility for the introduction and installation of the packaging process
  • Life cycle cost considered in designs for maximum long-term efficiency and reliability.
  • Follow site procedures in Project Management best practice, including PM methodologies, design, documentation management and standards.
  • Ensure scope is understood, communicated and locked through appropriate charter for the project.
  • Highlight and mitigate risks as early as possible.
  • Manage budgets to ensure control is maintained at all times.
  • Direct PFMEA studies and lead Risk assessments effort for the overall process
  • Design, develop and source packaging equipment, source tools, fixtures and specialist equipment as required for successful implementation and project delivery
  • Manage scope through approved change control for any changes.
  • Ensure the quality of all works completed is to the highest standards and on schedule.
  • Ensure all documentation is appropriately reviewed and signed off.
  • Coordinate and attend FAT’s as required.
  • Ensure validation methodology is clear and integrated into the project from URS onwards.
  • Ensure documentation, training and handover meet the customers’ expectations.

Contractor Coordination

  • Ensure contracts are binding and clearly linked to project scope, schedule, budget and specific skill sets.
  • Develop relationships with contractors. Ensure they understand our business and are compliant to site procedures.

Reporting and Governance

  • Provide timely and accurate reporting on project activities
  • Report covering 1) Schedule, 2) Cost control, 3) Project scope and 4) Risks and mitigations, compiled at appropriate intervals.
  • All Project related information stored centrally.

Health, Safety and the Environment

  • Comply with legislative requirements for construction projects.
  • Ensure Safety Management is paramount in project delivery processes.
  • Comply at all times with Health, Safety and Environmental policy and procedure.
  • 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, cGLP, SOP’s, regulatory guidelines.
  • Take ownership for quality compliance in all activities you are responsible for.
  • Assume responsibility for process / equipment and facility qualification and put in place a schedule for re-qualification.

Minimum Qualifications and Experience:

  • Qualified to a minimum of Degree level in an Engineering discipline.
  • At least 3 years Project Management experience, preferably in the Pharma sector.
  • Project Management.
  • Motivating cross functional Teams.
  • Knowledge of cGMP requirements.
  • Understanding of integrated validation approaches.
  • Knowledge of Lean Manufacturing processes.
  • Scheduling.
  • Ability to manage multiple conflicting demands and to prioritise accordingly.
  • Knowledge of Pharma packaging is essential.

Quality Systems Controller – Waterford City

Description:

To provide administrative support to the Quality Systems department

Responsibilities:

Documentation Vault maintenance including;

  • Document request management
  • Vault 5S Standards
  • Maintenance of personnel training folders
  • Maintenance of master batch folders

Documentation Archival including;

  • Archival of vault documentation
  • Processing of site archival requests
  • Control of archival returns

Scanning and filing of GxP documentation including;

  • Results Summaries
  • Out of Specifications
  • Cleaning Protocols
  • To assist in the preparation for customer / regulatory inspections to ensure efficient and accurate document retrieval.

To provide other necessary administrative support to the Quality Systems department including;

  • Purchase requisition/PO creation
  • GxP documentation transfer (between sites)
  • Reception cover

To ensure that all work carried out is in compliance with the required standards conforming to company, cGMP, cGLP, SOP’s, regulatory regulations and guidelines, safety and environmental guidelines.

Health & Safety:

  • Implement Safety requirements as per site documentation including SOPs, Safety Statement and COPs
  • Reports any Defects/hazards
  • If unsure about safety requirements – ask

Minimum Qualifications and Experience:

  • At least two years administration experience.
  • Strong attention to detail
  • Working knowledge of Word / Excel

Quality Assurance Specialist – Sterile Operations – Waterford City

Description:

Reporting directly to the Quality Assurance Team Leader, as a critical leader for our client, you will play an integral role within the Sterile Operations area, transforming the support provided to these functions.

Responsibilities:

  • Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues related to Sterile Manufacturing activities
  • Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
  • Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk
  • Work with relevant departments to ensure timely closure of quality actions / findings
  • Actively contribute to continuous improvement initiatives

Skills/Qualifications:

  • Previous experience in sterile operations in particular the management and manufacture and release of sterile product
  • Provide ability to provide quality expertise & support to the QA team and site
  • Proven ability to support the delivery of tasks in a highly regulated manufacturing environment
  • Effective technical knowledge of sterile manufacturing processes
  • Minimum 5 years’ experience working in a Sterile manufacturing environment
  • Effective technical knowledge of sterile manufacturing processes
  • Operational experience of quality systems in a dynamic manufacturing environment
  • Knowledge of requirements for cGMP, US and EU regulatory requirements
  • Full understanding of relevant quality and compliance regulations
  • Able to manage projects to plan/budget
  • Effective facilitator
  • Good communication skills at organisation, team and individual levels
  • Understands KPI’s for the team and site

QA Operations Specialist – New Product Introduction – Dublin

Responsibilities:

  • Provide quality and cGMP input and oversight focused on the transfer of new products to the site – through commercial readiness and ongoing product disposition for biologics facility.
  • Provide QA support for risk-based verification activities in the capacity of Quality Assurance Subject Matter Expert.
  • Support the introduction of all associated new materials, including qualification of the materials and associated vendors.
  • Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained / controlled.
  • Review and approval of technical support documentation. (Examples include associated technical transfer documentation, process, method validation)
  • Review and approval of manufacturing batch records.
  • Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols.)
  • Provide quality support for implementation of new product on SAP.
  • Authoring, review and approval of QA-related procedures.
  • Oversee the effective documentation and tracking of quality management system activities including deviations and change controls, CAPA, and batch disposition.
  • Review and approve Validation protocols and reports as required.
  • Support the vendor quality management programme.
  • Participate in regulatory inspections 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.

Skills/Qualifications:

  • B.Sc. in science/pharmacy/engineering with a minimum of 5 years’ experience in cGMP Quality environment
  • Min 5 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment. (BDS experience is an advantage).
  • Should 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.

Document Controller - Dublin

Responsibilities:

  • FirstDoc Coordinator via EDMS System
  • Copy, scan and store documents via Sharepoint
  • Receipt of Vendor and Contractor Turnover Packages
  • Check for accuracy and edit project files
  • File documents in physical and electronic copies
  • Create templates for future use
  • Retrieve files as requested by employees and contractors
  • Manage the flow of documentation within the BDS Project
  • Issue Documentation numbers
  • Updating project procedures and fillable forms
  • Documentation turnover transfer care, custody and control
  • Prepare ad-hoc project reports as required
  • Audit preparation
  • Any other duties as required by management

Minimum Qualifications and Experience:

  • 3+ Years’ experience in a similar role is essential for this position
  • Educated to Leaving Certificate standard (or equivalent)
  • Proven work experience as a Document Controller or similar role
  • Familiarity with project management
  • Hands-on experience with MS Office and MS Excel
  • Knowledge of Electronic Document Management Systems (EDMS)
  • Proficient typing and editing skills
  • Data organization skills
  • Attention to detail
  • 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

Document Specialist - Dublin

Responsibilities:

  • SharePoint owner setting up introduction of new employee access and providing guidance/ training
  • Assist with setup and manage Change Management, Deviation Management Logs
  • Collate routine metrics
  • Generating Procedures and Fillable Forms
  • Setting up General Filing Structure for BDS documentation
  • Updating of documentation as required
  • Review & approve documentation & other manufacturing documentation as needed
  • Generate, track and catalogue Manufacturing Records, Batch related documents and forms & Cleaning Verification sample packs
  • Summarise data
  • Provide documentation advice and training for BDS Project Team & the company’s Doc Control
  • Attend and or chair daily operations meetings as required
  • Audit Preparation
  • Any additional duties as required by manager

Minimum Qualifications and Experience:

  • 3+ Years’ experience in a similar role is essential for this position
  • Educated to Leaving Certificate standard (or equivalent)
  • Word, Excel, Power-point, Sharepoint
  • LIMs systems would be beneficial

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

CQV Lead Engineer – Labs - Dublin

Description:

Our client, a global leading biopharmaceutical company, is seeking an experienced Lead CQV Engineer – Labs for their large-scale biologics manufacturing facility.

Responsibilities:

  • CQV Engineer for development of labs, initially responsible for review of all design deliverables including drawings, datasheets, specifications and engineering system lists
  • Point CQV person for vendor review for all relevant vendor packages
  • Develop a schedule for all lab systems, perform and lead all field walkdowns
  • Lead CQV review, aligning with Transition Group in relation to review and approval of all turnover packages, both vendor and contractor packages within the lab / support area buildings
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation, ensuring all correct predecessors and successors are in place
  • Ensure commissioning readiness of all equipment systems for the lab areas from start-up and IOQ testing
  • Lead CQV review on all isometrics, weld logs, weld qualifications, 3rd party inspections, material of construction and redlining exercise for your area
  • Lead CQV interface with project database equivalent system, ensure full traceability at all times
  • Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all systems are managed appropriately for the entire project lifecycle
  • Liaise with CQV Document Generation Lead in relation to generation and approval of; DQ/Design Reviews/SLIA/Test Matrices/Risk Assessments/QA Vendor Assessments/FAT/SAT/CTP/IOQ protocols
  • Lead execution of all labs area CQV deliverables; such as FAT/SAT/CTP/IOQ
  • Generate and ensure timely approval of all commissioning and IOQ final reports

Minimum Qualifications and Experience:

  • Third level Degree in a relevant discipline
  • Minimum 10 years CQV LSCC experience on large scale projects
  • Working knowledge of ASTM E2500 / Leveraging Verification process
  • Experience with liaising with other departments and building PMs/leads
  • Minimum 10 years’ experience in leading a highly skilled CQV Team.
  • Experience with complex projects and working in or around operating facilities
  • Computer skills Spreadsheets, Word Processing, Visio, Microsoft Project
  • Full Microsoft Office Package

Lead CQV Engineer – CUB – Dublin

Description:

Our Client, a global leading biopharmaceutical company, is seeking a Lead CQV Engineer for their large-scale biologics manufacturing facility based in Dublin.

Responsibilities:

  • CQV Lead Engineer for CUB system and supporting systems
  • Aligning System boundaries, point CQV person for Vendor review for all black, clean, utilities and HVAC vendor packages
  • Assist CQV SME for all Black utilities and HVAC systems
  • Liaise in relation to construction readiness and a schedule for all black utilities and HVAC systems
  • Assist CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the utilities systems
  • Liaise with CQV SWAT Team in relation to punch list closure both pre-M/C and during the CQV execution phase for all Black, Clean Utilities and HVAC systems
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Process Equipment Support, ensuring all correct predecessors and successors are in place
  • Ensure Commissioning readiness of all Black, Clean Utilities and HVAC Systems to support Equipment Start-up and CQV Testing
  • Assist PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner
  • Master Project Database equivalent system, ensure full traceability at all times for all systems
  • Liaise with CQV Document Generation Lead in relation to generation and approval of; Design Reviews/SLIA/Test Matrices/FAT/SAT/CTP Protocols
  • Support execution of all Black, Clean Utilities and HVAC CQV deliverables; FAT/SAT/CTP
  • Run Weekly CQV Black, Clean Utilities and HVAC Meeting and ensure updates are provided to Weekly CQV Meeting
  • Generate and ensure timely approval of all SAT and or CTP Final Reports.
  • Minimum 8 years CQV Black, Clean Utilities and HVAC experience on Large Scale Projects
  • Working knowledge of ASTM E2500/Leveraging Verification process
  • Experience with liaising with other departments and building PMs/leads

Minimum Qualifications and Experience:

  • Minimum of 8 years of Black, Clean Utilities and HVAC experience including experience with design and construction projects for biopharmaceutical manufacturing facilities
  • Minimum 8 years’ experience in Black, Clean Utilities and HVAC CQV Team
  • Experience with complex projects and working in or around operating facilities
  • Ability to keep work pace and meet deadlines.  Good organising and planning skills
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff
  • Proven success working well in a team environment with flexibility to react to changing business needs
  • Strong leadership and communication skills.  Problem solver with a focus on achievement of overall project goals
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)

CQV Engineer –Utilities - Dublin

Description:

Our client is seeking a CQV Engineer for Utilities for a large-scale biologics manufacturing facility based in Dublin North.

Responsibilities:

  • CQV Engineer for Utilities supporting the HVAC systems, initially responsible for review of all Design deliverables, datasheets, specifications and engineering Lists
  • Assist CQV SME for utilities and HVAC systems
  • Liaise in relation to construction readiness for utilities and HVAC systems
  • Assist CQV review, aligning with Turnover team in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the utilities systems
  • Liaise with CQV Lead Scheduler in relation to schedule creation and progress reporting
  • Ensure Commissioning readiness of all Black, Clean Utilities and HVAC Systems to support Equipment Start-up and CQV Testing
  • Assist PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner
  • Master Project Database equivalent system, ensure full traceability at all times for all systems
  • Liaise with CQV Document Generation Lead in relation to generation and approval of; Design Reviews/SLIA/Test Matrices/FAT/SAT/CTP Protocols
  • Support execution of all Black, Clean Utilities and HVAC CQV deliverables; FAT/SAT/CTP
  • Assist with Weekly CQV Black, Clean Utilities and HVAC Meeting and ensure updates are provided to Weekly CQV Meeting
  • Generate and ensure timely approval of all CQV documentation.

Minimum Qualifications

  • Minimum 8 years CQV Black, Clean Utilities and HVAC experience on Large Scale Projects
  • Working knowledge of ASTM E2500/Leveraging Verification process
  • Experience with liaising with other departments and building PMs/leads

Knowledge and Skill:

  • Minimum of 8 years of Black, Clean Utilities and HVAC experience including experience with design and construction projects for biopharmaceutical manufacturing facilities
  • Minimum 8 years’ experience in Black, Clean Utilities and HVAC CQV Team
  • Experience with complex projects and working in or around operating facilities
  • Ability to keep work pace and meet deadlines.  Good organising and planning skills
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff
  • Proven success working well in a team environment with flexibility to react to changing business needs
  • Strong leadership and communication skills.  Problem solver with a focus on achievement of overall project goals
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)

Senior Quality Officer – Waterford City

Description:

The Senior QA Officer will manage and co-ordinate Quality Assurance activities and resources associated with the Pharmaceutical manufacturing and release of Products. They will be responsible for facility compliance with regulatory commitments, in-house requirements and cGMPs.

Responsibilities:

  • Responsible for facility compliance with regulatory commitments, in-house requirements and GMP
  • Preparation of procedures and policies for area of responsibility
  • Responsibility for maintenance and development of GMP awareness facility-wide, including: preparation and execution of training programmes, assessment of GMP training requirements, and execution of internal GMP auditing
  • Investigation for QA review of all GMP critical documents and documentary review
  • Participate and manage in the introduction and maintenance of Global Quality Management Systems (GQMS)
  • In-house auditing and line clearance procedures
  • Exception and deviation management e.g. deviations, Alarms, OOS, etc
  • Support quality aspects of materials management including supplier approval, supplier complaints and specification management
  • Provision of support and assistance in execution and control of validation programmes

Regulatory Activities:

  • Maintenance of site master file
  • Preparation of annual reports and activities i.e. Product Quality Review, Mock Recall etc
  • Trending of complaints
  • Maintain manufacturing licence, variations etc

General and Environmental Standard Operating Procedures:

  • Participate in team based project work and plant-wide initiatives to improve the GMP compliance and financial performance of the Envision area
  • Other duties as assigned supervision management

Key eGMP Responsibilities:

  • Maintain, develop and manage QA systems
  • Follow Standard Operating Procedures while carrying out duties at all times
  • Participate fully in all GMP and operational programs and complete all Training Records in an accurate and timely manner

Minimum Qualifications and Experience:

  • Third level Qualification in Science
  • Minimum 3-5 years’ experience in a regulated pharmaceutical with at least 2 years in a senior Quality Role preferable
  • Full understanding and experience of the requirements of Pharmaceutical Regulations, CGMP Guidelines, ISO 13485
  • Must have ability to analyze and provide Quality Direction on product / equipment issues using independent judgement
  • Must be self-motivated, with ability to work on own initiative and prioritize
  • Must have experience of team working and excellent communication skills
  • High attention to detail

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