Pfizer Grange Castle, Dublin
The role is to support the validation of the equipment adopting the Verification approach. Tasks will include generating, reviewing and approving documentation, test execution, participation in reviews, risk assessments etc. Equipment includes bioreactors, centrifuges, chromatography, virus filtration, CIP & SIP systems
The role will involve:
- Taking ownership of specific system(s)/package(s) in terms of project management of Verification scope of work including documentation generation, reviews and approvals and test execution to meet project milestones. This may also involve managing contractors/vendors performance, quality of work and their deliverables to meet project milestones
- Liaising with the Engineering company and vendors throughout the design phase to ensure equipment/facility design meets requirements/specifications
- Identifying and escalating issues/risks to the project as required
- Working pro-actively with the team to resolve issues in a timely manner to meet project timelines
- Critiquing of verification results to ensure systems released are robust and fit for use
The role will support execution of the Engineering/Demonstration batch phase following completion of verification activities.
- Generating, approving and executing of Verification Tests Plans and Scripts / protocols, and reports.
- Generating and managing events / deviations / engineering change controls.
- Execution Verification / CQV works utilising the necessary Pfizer safe systems of work
- Ensuring all Pfizer and engineering policies and procedures are adhered as applicable
- Scheduling and coordinating work to tight deadlines.
- Providing progress updates for systems/equipment and maintaining project progress to agreed timelines.
- Interface with in-house customers, project groups and QA as required in the delivery of the project. Providing progress updates for systems/equipment and maintaining project progress to agreed timelines.
- Identifying, escalating and resolving issues in a timely manner as required
- Support Water and Engineering/Demo batches
- At least 2 years of experience working in the verification or CQV of equipment.
- Strong evidence of problem-solving skills
- Excellent documentation practices.
- Good communication skills
- Experience and understanding of the importance of following site quality, validation and engineering procedures.
- Aptitude for technical learning, technical writing and problem solving individually and as part of a team.
- Ability and experience of managing, prioritizing and delivering assigned work to meet project, customer and/or departmental requirements
- A minimum of a B.Sc., B.E. or M.Sc./M.Eng. Degree in Biosciences, Chemical Engineering or equivalent; equivalent defined as a Biotechnology or Industrial Chemistry Degree with a large element of engineering fundamentals as applied to biotechnology in the curricular.