Cpl, in partnership with our client Pfizer, are currently recruiting for a Process Scientist / Engineer to work in their state of the art biopharmaceutical facility in Grange Castle, Dublin West.
This role is to support the completion of validation activities and support of license application US / EMEA for next generation multivalent Meningococcal Conjugate Vaccine.
Job Responsibilities
- Completion of on-going Process Validation Activities, compilation of validation supporting data and write up of process validation reports and ancillary validation reports (resin lifetimes, filter validation, comparability reports etc..) in accordance with current cGMP and Pfizer quality standards (including PQS).
- Authoring of S.2.2, S.2.3, S.2.4 & S.2.5 according to project timelines to support planned BLA and MAA Regulatory filing dates
- The role requires close liaison with Vaccines development organization & Pfizer CMC on Product filing
- Provide SME leadership to the project on significant validation issues in support of project milestones and major investigations.
- Provides SME expertise and guidance on validation and qualification life cycle requirements as defined by regulatory and Pfizer quality standards and procedures e.g. Risk assessments, Control Strategies, Validation Plans, GMP requirements, SME input to verification testing and validation summaries including deviations and change controls. .
- The role requires liaison with stakeholders and partners in Operations, Manufacturing Sciences and Technology (MSAT), Quality and Regulatory functions.
Experience
- A senior technical SME in biopharmaceuticals with good knowledge of current cGMPs and other regulatory guidances (ICH Guidelines, EMA Annex 15, FDA PV guidance 2011, etc.). Broad experience across a range of technical areas would be advantageous eg. cell culture, vaccines conjugation, clinical and commercial production, etc.
- Excellent communication skills to liaise with senior stakeholders across site and the Biotech OpU are key requirement.
- A minimum of 5 years experience providing validation and/ or licence application support.
- Validation leadership working in biopharmaceuticals is preferable. Experience of presenting complex technical issues in cGMP audits and inspections would be an advantage.
- Previous experience of process validation execution with Pfizer or in other biopharma companies is preferable.
- Experience of working with cGMP systems in the biopharmaceutical industry is required, particularly in making complicated product quality impact assessments.
- Experience delivering significant work packages for major process tech transfers
- Strong evidence of problem-solving/trouble-shooting skills
- Knowledge of good bioprocess equipment design.
Education
- A minimum of a B.Sc., B.E. or M.Sc./M.Eng. Degree in Biosciences or Biochemical/ Chemical Engineering or equivalent. Qualifications in bioprocess or analytical-related disciplines preferred.
This role is a contract position. Interested applicants should apply with up to date CV or email it to [email protected]. Applicants must have unrestricted right to work in Ireland (i.e. EU Citizen or relevant work permit).