Senior Process Engineering Lead is required by CareerWise Recruitment for our Cork based client.
The successful candidate will be responsible for contributing to the technical management and oversight of multiple injectable commercial pharmaceutical products. This is senior position with matching salary and benefits package on offer.
Role of this position
- Oversees and contributes to the completion of all technical and operational activities related to maintaining commercial product supplies through management of external resources.
- Responsible for lifecycle management of commercial products including scale-up, validation, Continued Process Verification and technology transfer between sites to ensure production schedules are met.
- Technical expertise in parenteral manufacturing areas such as; compounding, aseptic filling, lyophilization, capping, inspection, aseptic practices, sterility assurance studies
- Coordinates equipment/process qualification (IQ/OQ/PQ) and executes process validation (PV); writes, reviews and/or approves qualification/validation/technical reports.
- BS or MS degree in Engineering or Science field, preferably in Chemical Engineering, Pharmaceutical Sciences/Engineering or Mechanical Engineering.
- Good understanding of/experience with applied statistics and data analysis.
- Excellent verbal, written, and interpersonal communication skills, with experience writing technical reports.
- Strong knowledge of Good Manufacturing Practices (GMPs), working knowledge of regulatory filing requirements and guidance documents (i.e. SUPAC, PACPAC) and compliance for sterile injectable products manufactured by aseptic processing.
- Considerable experience in the pharmaceutical industry and a BS or BA or relevant experience and a MS.
Please call Mike Morrissey today for further information on 021-429 7536 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)