Process Validation Engineer
Piper Companies is seeking a Process Validation Engineer for the MS&T group of a local biopharmaceutical company. The Engineer will provide expert technical support to Commercial Operations, both Bulk Manufacturing and Fill/Finish. They will be specifically dedicated to supporting a critical process validation in a large cell culture manufacturing facility.
Responsibilities for the Process Validation Engineer:
- Assembling and reviewing all information required for the PPQ report
- Helping with the creation, authoring, and review/approval of the PPQ reports
- Experimental support for deviations or manufacturing investigations
- Process troubleshooting, Raw Material evaluation, Planning and execution of validation programs
- Continuous process monitoring and improvement
- Responsible for analyzing and drawing accurate conclusions and recommendations from the process and experimental data.
Qualification for the Process Validation Engineer:
- Bachelor’s degree in a relevant technical discipline (Chemical Engineering or Life Sciences)
- Minimum 2-5 years hands-on process validation experience
- Experience in the medical device and/or FDA regulated industry.
- Knowledge of large scale biotechnology unit operations, principles of SIP and CIP, principles of biochemical engineering, and process data analysis.
- Understanding of compliance and cGMP considerations.
- Demonstrated commitment to continuous improvement – at the individual, department and organizational levels.
- Knowledge and application of a disciplined project management process.
Compensation for the Process Validation Engineer:
Salary: $85,000 - $100,000
Full Benefits: Medical, Dental, Vision, Paid time off, and 401K