Piper Clinical Solutions is actively seeking a Senior Process Engineer to work at a well-established biopharmaceutical company in the Raleigh / Durham area.
Responsibilities for Senior Process Engineer:
- Technical transfer of upstream processes for large scale manufacturing.
- Prepare for transfer of methods through scheduling personnel, conducting facility fit evaluations, ordering materials, etc.
- Review process descriptions and create process flow diagrams using Microsoft Vizio.
- Assess and document any deviations and work with the quality assurance team to write corrective and preventative actions.
- Conduct quality risk analysis and report findings in Quality Risk Management System (QRM).
- Participate in project team meetings and report all project activities to clients and upper management.
Technical Requirements for Senior Process Engineer:
- Bachelor’s or Master’s degree in chemical engineering or related field.
- Minimum 3 years hands on experience with tech transfer in upstream manufacturing.
- Hands on experience with mammalian cell lines and single-use bioreactors.
- Experience working with Microsoft Vizio and Quality Risk Management Systems.
- Experience with PPQ (process performance qualification) or process validation experience preferred.
- Excellent organizational skills and proven experience working in a fast-paced environment.
Compensation & Benefits for Senior Process Engineer:
- Compensation: based on previous salary history and experience
- Full Benefits: Medical, Dental, Vision, 401k
Qualified candidates please send resumes to Meg Smith at firstname.lastname@example.org
Keywords: upstream, cell culture, biologics, pharmaceutical, process engineer, process validation, vizio, bioreactors, senior engineer, PPQ, PQ, OQ, technology transfer