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.


WATCH PROMO VIDEO

TECHNICAL RESOURCING

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

R&D Data Reviewer - Waterford CIty

Description:

Our client a leading Pharmaceutical company based in Waterford requires an Analytical Development Data Reviewer to support Product Development and Clinical Supply and review all data associated with developing, transferring or validating analytical test methods as applicable.

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline.
  • At least five years’ experience working in a related technical environment.
  • Proficient in the use of HPLC & associated problem solving.
  • Working knowledge of Empower laboratory software.
  • Strong attention to detail.
  • Strong analytical ability. 

Responsibilities:

  • Review all data associated with the development, transfer or validation of robust, sound analytical methods
  • Review test methods, validation protocols and reports as applicable
  • Prepare submission documentation in support of license applications
  • Take part in /lead Laboratory Investigations
  • Attend internal project review meetings as required
  • Assist in the preparation for customer/ regulatory inspections
  • Identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement
  • Review raw data from the testing of raw materials, in-process samples and finished products in a timely & efficient manner to ensure quality and efficacy of the product
  • 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
  • Review all data to ensure that it is completed 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
  • Perform additional team tasks as agreed to support effective running of the Business
  • Support all other on-going laboratory functions & requirements

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

Laboratory Training Specialist - Waterford City

Purpose:

To support QC/Stability, and Technical Service departments by ensuring all training related issues within the departments are executed correctly and efficiently.

Responsibilities:

  • Develop and maintain a robust laboratory training plan for all roles within the Laboratory.
  • Review the trends from training related deviations and propose effective preventative actions related to training requirements.
  • Review training metrics for compliance.
  • Evaluate the effectiveness of training for specific roles.
  • Assist in new Learning Management System implementation and maintenance from laboratory updates.
  • Liaise with Team Leaders & Managers to co-ordinate the induction and training of new laboratory staff as appropriate.
  • Prepare and deliver training presentations as required.
  • Ensure all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • Assist in the preparation for internal / customer/ regulatory inspections.
  • Draft, review or revise documentation within Eigen documentation management system
  • Health & Safety
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
    • Report any defects or hazards
    • Ensure all laboratory personnel are suitably trained on any  safety requirements for working in the laboratory.

Minimum Qualifications and Experience:

  • A relevant qualification in Analytical Chemistry, Pharmaceutical science or related discipline.
  • At least three years experience working in a regulated environment. Experience in both testing and data reviewing is preferable with a proven track record of compliance in theses area.

Manufacturing Engineer (Projects) - Athlone

Description:

The Manufacturing Engineer (Projects) is required to act as the Engineering Team’s representative for ongoing projects. The manufacturing engineer (projects) will be responsible for overseeing projects ranging in nature from New Product Introduction, to improving machine capabilities and implementing continuous improvement projects. The right candidate will also ensure the projects comply with the relevant regulatory requirements as well as company specifications and requirements. This role will include design, scope definition, change control and project management.

Responsibilities:

  • Responsible for Manufacturing Engineering Projects, liaising with vendors and troubleshooting of process systems where required.
  • Participate on capital project teams through all phases of projects; these phases will include conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification.
  • Responsible for initiation and completion of deviations, CAPAs, and change controls for process systems including investigations relating to equipment malfunctions.
  • Oversee process system upgrades
  • Any other duties as required by management

Minimum Qualifications and Experience:

  • BEng in Chemical or Mechanical Engineering plus 3-4 years relevant experience in a cGMP commercial manufacturing environment or MS or MEng in Chemical or Mechanical Engineering plus 2-5 years relevant experience in a cGMP commercial manufacturing environment.
  • 3-6 years relevant experience in a cGMP commercial manufacturing environment (preferably Biopharma)
  • Experience in project management of small scale projects in a cGMP commercial manufacturing environment
  • Experience in troubleshooting and providing technical support for cGMP manufacturing operations and equipment in an aseptic processing environment
  • Experience with sanitary design and operation of manufacturing equipment, with an emphasis on Aseptic Filling (for both or either RABs or Isolator technology)
  • Ability to read and understand sophisticated architectural, equipment and system drawings.
  • Knowledge of and experience with GMP manufacturing systems (i.e. filling machines (Isolator and RABs technologies), ultrafiltration systems, autoclaves, parts washers, etc.)

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.

Technical Services Specialist – Upstream - Dublin

Purpose:

The Cell Culture (Upstream) Technical Specialist has primary responsibility in supporting the startup and cGMP manufacture of biological bulk drug substance (BDS). The Technical Specialist will be part of the cell culture team to support the facility start-up and routine commercial manufacturing from small scale and large scale media preparation, vial thaw, through typical scale up processes, to seed and production bioreactors, with harvest and clarification technologies respectively. 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, Operations, Engineering, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility startup and process qualification. The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Technology Transfer, supporting start-up studies, building process data packs and performing process monitoring, study protocol generation, execution and report writing.

Responsibilities:

  • To provide technical process support in the area of media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors) to support the successful startup
  • Working knowledge of typical cell culture unit operations, cause and effect, collation of data and trends. Performing process monitoring/trending.
  • To author and review process supporting documentation, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.
  • 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.
  • Partner with Operations to support protocol completion, execution and sample reconciliation.
  • To generate documentation reports for plant supporting studies and technical studies on the manufacturing floor at commercial scale.
  • May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution, as well as any other duties as required.
  • To provide on the floor support for troubleshooting processing issues and to participate in closeout of manufacturing investigations into process deviations and resolution.
  • Lead any key process changes using change control management system as required.
  • 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 audits and incident investigations.

Minimum Qualifications and Experience:

  • Minimum requirement would be B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering. A higher degree (M.Sc. or Ph.D.) would be an advantage
  • Minimum 1-2 years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.
  • Technical and operational knowledge of multiple unit operations in upstream processing, including media preparation, mammalian cell culture, centrifugation & depth filtration.
  • Understanding of technology transfer, scale-up process and cleaning verification/validation is advantageous.
  • Understanding of cGMP requirements for commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
  • 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.
  • Detail orientated.
  • Technical writing competency.
  • Self-driven to do the right thing.
  • Enjoy a fast paced working environment with broad levels of engagement and insight for self-development and experience gain in a startup environment.

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.

Formulation Development Team Lead

Responsibilities:

  • To coordinate and lead all R&D and Operations related formulation development activities and to ensure strict adherence project plans
  • To perform all activities required to ensure that all R&D project milestones are delivered according to agreed timelines.
  • To work closely with PMO to ensure all work stream leads are appointed to all ongoing projects and all planned tasks are being progressed.
  • 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-vivo data for the purposes of further formulation development.
  • 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.
  • Identify, assess, recommend and implement internal and external opportunities to broaden EirGen Pharma’s technical/scientific capability.
  • Project Planning:
    • 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.
    • Determine tasks and resources 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, safety and environmental guidelines. 
    • Initiate action to correct quality/schedule problems or notify others of quality issues as appropriate. If a procedure does not exist, devise one; if a process needs amending, do so.
    • 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 cGMP. 
    • To prepare pharmaceutical development 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 EirGen 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
    • If unsure about safety requirements – ask

Minimum Qualifications and Experience:

  • Qualified to a minimum of honours degree level in Pharmaceutical science or related discipline. Master’s degree would be advantageous
  • At least five years’ experience working in a formulation development, or related technical environment
  • Experience in effectively operating both GMP and Non-GMP areas
  • Pre-formulation experience, including drug characterisation and ingredients selection
  • Formulation studies, considering such factors as particle size, polymorphisms, pH and solubility, as all can influence bioavailability and drug activity
  • Supervisory/ management experience essential
  • Analytical/ laboratory experience would be advantageous
  • Project management and team leadership skills are essential
  • Have demonstrated effective research skills, including the critical review of the scientific literature

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

Warehouse Associate - Dublin

Description:

The Warehouse Operator is responsible for the day to day warehouse activities at the Dublin facility. They are responsible for ensuring that all warehouse activities are completed as per approved Standard Operating Procedures (SOP’s), in a safe manner and in compliance with current Good Manufacturing Practices (cGMP). The individual in this position is expected to represent the companies Pharmaceutical interests, objectives and policies in a professional and responsible manner.

Responsibilities:

  • Ensure all training on equipment, processes, and facility and safety procedures are maintained and up to date at all times.
  • Perform day-to-day warehouse activities to meet schedules while maintaining a high level of GMP compliance.
  • Maintaining the Warehouse Quality System by adherence to all relevant SOP’s, policies and cGMP requirements.
  • To aid with troubleshooting and resolving operational problems.
  • Act as a subject matter expert for the Warehouse group in relevant equipment and system root cause investigations and fill the role of lead investigator where required
  • Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
  • Carry out dispensing activities in a controlled environment
  • Report to Warehouse Supervisor on a regular basis on area performance and report any issues that need to be resolved.
  • Proactively ensuring that all Environmental, Health and Safety responsibilities are carried out according to EHS regulations and procedures.
  • Maintaining spare parts, change parts etc. in the Engineering Stores.
  • Utilising and maintaining IT systems as required, e.g. SAP.
  • Provide support to Operations, Validation, Engineering and Quality where required.
  • Complete training with new/junior Warehouse Operators.
  • Other duties as required.

Minimum Qualifications and Experience:

  • Current or previous formal education in logistics/warehousing/supply chain would be an advantage.
  • 2-5 years’ experience performing Warehouse support activities preferably in a cGMP commercial manufacturing environment.
  • Previous experience with dispensing activities preferred
  • Must be able to work within and adapt to complex electronic systems such as SAP.
  • Good interpersonal, communication and problem solving skills.
  • Should be knowledgeable of regulatory and GMP requirements

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.

Operational Readiness Project Manager – Dublin

Responsibilities:

  • Manage cross functional operational efforts to ensure smooth transition from CQV to operational phase of Bulk Drug Substance project
  • Plan all Operational Readiness activities
  • Coordinate activities across multiple work streams
  • Work with other project managers to ensure cross functional dependencies are factored into all plans and are updated as necessary
  • Work with the work stream leads to ensure all activities can be resourced and that deadlines can be met
  • Report progress and potential impediments
  • Communicate prioritisation and operational decisions to the broader cross functional team to drive consensus and ensure that those decisions are properly implemented.
  • Facilitate relationships between work streams, move initiatives forward, raise concerns to appropriate owners early and resolve issues that prevent progress
  • Hold people accountable when schedule or progress issues arise while maintaining respectful relationships
  • Predict roadblocks and obstacles, establishing meetings or integration points between teams
  • Prioritize competing needs with good reasoning and creative solutions
  • Contribute to project processes, tracking tools and general project management best practices and initiate improvements where needed.
  • Monitor execution of the plan and escalate issues/risks to Operations Snr Management
  • Any Other duties as required.

Minimum Qualifications and Experience:

  • Technical Degree in Engineering/Life Sciences or greater preferred
  • 3+ years of experience initiating and driving projects to completion with minimal guidance
  • Demonstrated experience influencing across functional boundaries
  • Ability to communicate to and work with all levels of the organisation
  • Analytical, problem solving, negotiation and organizational skills.
  • Ability to stay focused under pressure, prioritising and managing multiple tasks  simultaneously in a fast paced environment.
  • Extensive experience in Bulk Drug Substance Manufacturing
  • Understanding of Operational Readiness
  • Good interpersonal skills

Cleaning Validation Specialist – Dublin

The Cleaning Validation Technical Specialist will support the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at the facility in Dublin. The Specialist will provide cleaning validation expertise to support the facility design, start-up and routine commercial manufacturing. The Cleaning Validation Technical Specialist will be responsible for validation and verification of the cleaning used to support the technology transfer of new or existing drug substance manufacturing processes to the facility, and will be required to work in close collaboration with Process Development, Engineering, Supply Chain, Quality, Regulatory and other involved departments to ensure successful facility design, construction, startup and qualification. The position is accountable for timely completion of cleaning validation/verification related milestones, with particular emphasis on cleaning validation for a multi-product drug substance manufacturing facility.

Responsibilities:

  • Maintain/update input to the Cleaning/Validation Master Plan to support the startup of the multi- product drug substance manufacturing facility
  • Develop and implement/update cleaning strategies for fixed and mobile parts
  • Development/update and/or optimize cleaning (CIP) cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment
  • Generate and execute cleaning validation protocols as required. Provide input to Standard
  • Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities to occur
  • Work closely with colleagues within the Technical Services team, and with Quality, Commissioning, Manufacturing Operations, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of startup, technology transfer, and routine manufacturing timelines in the context of cleaning verification/validation
  • Author and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents and supporting documentation as required
  • Prioritize cleaning verification/validation activities in line with the project schedule to ensure product submission timeline is met, and regulatory approval attained
  • Identify requirements for process, plant, or laboratory studies/trials to support cleaning verification/validation activities and to liaise closely with Operations/QC to oversee the design and execution of studies (as required)
  • Identify and implement improvements where feasible
  • Lead the execution of cleaning trials and studies on the manufacturing floor at commercial scale relating to typical BDS manufacturing areas. Temporary shift working may be required during periods of engineering batch and validation batch execution
  • Provide on the floor support for troubleshooting cleaning related issues and may lead manufacturing investigations into process deviations
  • Author and review technical documents for SOPs, master data, material specifications and/or regulatory agency submissions which related to cleaning activities
  • Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections

Skills/Qualifications:

  • Minimum requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering
  • Minimum 5 years’ experience in Technical Services / Manufacturing / Technical
  • Development/Quality Support in a biological bulk drug substance manufacturing organization
  • Technical and operational knowledge of Cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities
  • Experience of cleaning validation is a must, and/or cleaning approaches to multiproduct is advantageous
  • Experience of cleaning verification/validation of downstream processing equipment (Chromatography skid, UFDF/TFF skids, Filtration skids, and process hold vessels)
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization
  • Ability to present and successfully defend technical and scientific approaches in both written and verbal form
  • Ability to drive for results independently and adapt to rapidly changing priorities

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

New Materials Introduction Planner - Dublin

Description

The NMI Planner has overall responsibility for the planning and project management of the introduction of new GMP raw materials for the manufacture of multiple Bulk Drug Substances at the Dublin Manufacturing Facility. The NMI planner must work closely with Technical Services, QA, QC, Warehouse, BDS Operations (end user), and with the Buyer to coordinate requirements, generate and oversee project plans to procure new materials requirements for multiple new products that will be introduced into the BDS facility. The key responsibility for this person is to ensure that all materials have their SAP master data created, material risk assessments and material specifications in place and are available onsite, tested and released by QC and QA as needed for use in the relevant tech transfer and manufacturing of drug substances, according to agreed new product introduction and commercial manufacturing schedules.

Responsibilities:

  • Identify Requirements and Suppliers
    • Coordinate with Technical Services who will provide process descriptions and create bills of materials and with the strategic sourcing team and buyer to identify suitable suppliers, grades and pack sizes according to process requirements and following standard operating procedures for NMI.
    • Work with Technical Services, Operations and Strategic Sourcing to ensure that the correct quantities are estimated to support technical studies, shakedown and engineering batches each new product introduction up to and including the process performance qualification batches (PPQ)
  • Qualify new Vendors and New Materials
    • Coordinate with QA, QC and Technical Services who are responsible for qualifying and adding new vendors and/or materials to the approved vendor list.
    • Coordinate and plan the generation of technical risk assessments and material specifications by Technical Services and QC respectively.
  • Purchasing
    • Coordinate with the Buyer to complete purchasing activities for all raw materials and components on the BOM, as well as any new consumables via the on-site vendor managed inventory service provider.
    • Work with Manufacturing and other site departments to understand future material needs and develop a purchasing schedule.
    • Support the Buyer as required to process purchase requisitions, enter purchase orders in SAP, and generate reports for upper management review.
    • Support Raw Materials and SAP Process teams – identify problems, recommend process improvements, and work with the team on resolutions.
  • Planning/ Scheduling
    • Produce BDS Master Schedules/ Plans as assigned and in conjunction with the buyer ensure that these are translated into SAP process orders in order to initiate MRP
    • Create Process Orders in SAP to initiate batch manufacture and coordinate with the finite scheduler to execute the BDS production schedule.
  • Any Other duties as required by Management

Skills/Qualifications:

  • 3rd level qualification in Business, Materials Management or Supply Chain Management/ Logistics or other equivalent such as APICS qualification.
  • Alternatively a science based 3rd level qualification, coupled with industry experience of aspects planning or management of raw materials and with the skills described below.
  • Proficient in use of SAP ERP system, preferably including familiarity with requirements and processes for material master data build and Bill of Materials creation, purchasing, MRP and production planning.
  • Project management skillset.
  • Planning experience in an MRP environment.
  • Understanding of cGMP raw material purchasing requirements
  • Excellent interpersonal and communication skills.
  • Customer service oriented, self -directed, responsible, and able to work on problems involving various cross-functional groups.
  • Ability to drive for results independently and adapt to rapidly changing priorities. Demonstrated ability to expedite and drive schedule adherence on an ongoing basis

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.

CQV Engineer – Dublin

Description:

The CQV Engineer performs activities to support the validation activities of our client’s cGMP manufacturing plant in Dublin. This includes supporting validation actions for Packaging and Warehousing facility, and temperature mapping of various units / areas. The role is a contract position as part of the CQV team.

Responsibilities:

  • Technical Application
  • CQV documentation – drafting, reviewing and approving CQV documentation to Regulatory standards and guidelines.
  • To co-ordinate and execute Periodic Review and Requalification of systems and facilities.
  • To co-ordinate and execute validation activity for new product introduction, or changes to secondary packaging processes.
  • Accountable for scheduling, tracking, reporting and achieving validation deadlines.
  • Input into the core aspects of Operations, Qualification and Validation SOPs.
  • Actively contribute to project teams.
  • Data gathering and analysis
  • Performing data analysis and determine conclusions reached.
  • Make informed decisions / recommendations around conclusions reached from data analysis.
  • Reviewing and approval of data analysis and reporting.
  • Information transfer
  • Attends departmental and team meetings focused on CQV activities.
  • Serve as a CQV representative for internal technical group discussions.
  • Compliance
  • Understanding and applying industry specific compliance standards/regulations to all
  • Commissioning/Qualification activities with focus on ASTM E2500, Eudralex and FDA standards.
  • Developing an understanding of the importance considering impact on cGMP and compliance on decisions made.
  • Conducting and participating in Risk assessments, root cause analysis and investigations.
  • Signing off and approving protocols, reports, project change controls and deviations.
  • Proactively highlighting any issues around compliance.
  • Participates in internal and external audits and inspections where required.
  • Learning and self-development
  • Willingly accepting challenging assignments
  • Proactively keeping up to date with current thinking and best practice
  • Seeking developmental projects / opportunities and tasks to improve personal knowledge and capability
  • Any Other duties as required by management

Minimum Qualifications and Experience:

  • Technical diploma or Degree in Engineering/Life Sciences or greater preferred
  • Commissioning, qualification and validation experience in GMP product manufacturing would be required (minimum of 3 years)
  • Thermal mapping experience using an independent thermal mapping system
  • Experience in HPRA/FDA environment advantageous
  • Strong technical writing and communication skills
  • Ability to close items to completion
  • Ability to pay high level of detail and QA data to very high standard
  • Problem solving skills
  • Must be goal-oriented and able to prioritize and manage risks

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

Quality Manager – Waterford City

Responsibilities:

  • To manage the compliance within the dept. and ensure that the area is operating in accordance to GMP
  • To provide support on any external investigations
  • To lead continuous improvement activities and support projects
  • Assist in any validation activities that may as the Quality representative within the project
  • To oversee the product and process performance using appropriate metrics Quality representative on the sign off of change controls, documentation and validation activities
  • To ensure that the procedures are up to date and in compliance to the global systems.
  • To ensure that the records generated are accurate and completed in real time.
  • To review method validation protocols and reports on new/ existing test methods, as required.
  • To liaise with other departments on the communication of the true failures and supply support for any further investigation or documentation required to close out the failures.
  • To approve all reports generated due to any investigational work that is requested due to a complaint or a potential issue within the manufacturing site.
  • To ensure that the data generated is accurate and generated in a timely manner to help close out issues and potentially release product.
  • Participate in inter-dept teams, as required to help improve.
  • Carry out all activities in compliance with company Safety Environmental Standard Operating Procedures.
  • Ensure that the activities completed during processing will not hinder the safety of other individuals within the area.
  • During validation activities support and risk manage process change initiatives to ensure appropriate level of validation and verification.
  • Lead projects for the introduction of new equipment within the site, ensuring that the correct level of validation is completed, that the relevant procedures are updated, and that there is a training plan in place.
  • Carry out Supplier Audits and internal audits when required.
  • Work in partnership with operations and Process engineering and other support departments to drive quality and cost Improvement initiatives
  • Additional requirements of the job will be specified by the Quality Director

Skills/Qualifications:

  • Degree in chemistry, science or related technical discipline
  • Experience as a working QP required
  • Full understanding of the requirements of the Regulatory Standards
  • The ability to assess and evaluate information to determine appropriate risk and required actions that are critical
  • Experience of scientific report writing including such documents as SOPs, protocols, deviations, reports etc
  • Have managed a QA department for 5 years
  • Ability to evaluate and assess information to determine appropriate risk and required actions is critical.
  • Good knowledge of Tablet manufacturing required
  • Experience in Medical Device manufacturing desirable
  • Knowledge of purified water and Environmental Monitoring systems

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.

Packaging Operations Manager - Waterford City

Description:

The Packaging Operations Manager will work directly with the Head of Operations in the set up phase of our client’s new packaging facility which will handle 1st and 2nd stage packaging. The role is responsible for the day to day operations of the packaging department to ensure all internal / external customer requirements are met as well as developing procedures for packaging associates

insuring customer and quality requirements are adhered to.

Skills/Qualifications:

  • Significant experience with desktop and software applications
  • Bachelors Degree in a related discipline
  • 6+ years of experience in pharmaceutical industry, with at least 3 years of managerial experience
  • Excellent communication, interpersonal and presentation skills
  • Analytical Decision Making and Problem Solving Skills
  • Performance Management and People Development
  • Ability to manage multiple conflicting demands and to prioritise accordingly
  • Ability to define and manage own tasks and schedules

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