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The process engineer will provide project leadership and technical expertise for a new Fill/Finish facility with terminal sterilization.
- Client-side lead to work with equipment vendors to support the equipment lifecycle activities as part of a new facility start-up project.
- Project management & subject matter expertise for a pharmaceutical fill/finish facility with terminal sterilization operations.
- Equipment lifecycle support from concept design, vendor selection, detailed design, build, CQV through to commercial operation.
- In-depth knowledge of primary vendor equipment and technology including; a bulk drug product compounding suite supplying a filling system (vial/syringe/bags) with open RABS technology and terminal sterilization.
- In-depth knowledge of secondary vendor equipment and technology including; Parts washer, autoclave technology, and clean utility services.
- Responsible for developing and executing the equipment lifecycle activities. This will include writing URS documents, review/approval of Design Specifications, input into the control strategy, development and execution of the test matrix (leveraged) to support offsite/onsite execution (as per ASTM E2500).
- Experience of working with equipment vendors through the key stages of the equipment lifecycle, including; procurement, design, build, FAT, install and SAT.
- Knowledge of supporting a ‘best practice’ methodology to help deliver a science and risk-based approach to CQV for a greenfield project start-up.
- The candidate should have strong leadership, direction, and organizational planning skills to support the team through each stage of the project.
- The role includes the need to develop and support the implementation of site procedures for robust and compliant GEP systems.
- Self-motivated and passionate starter.
- Team player who embraces collaboration for project success.
- Ideally, degree qualified; in Engineering, technical or science related field.
- 5+ years of progressive experience in a project engineering role within a pharmaceutical (fill/finish) operation, including a thorough working knowledge of EU GMP, FDA cGMP, GAMP 5, ICH guidelines, and GEP guidelines.
For a confidential discussion and more information on the role, please contact David Lennon on 090 64 78104 or email firstname.lastname@example.org