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Senior Process Engineer
2 months ago
Job Functions:
- Leading the packaging equipment specification, procurement, installation and qualification activities. This includes managing portions of the capital budget and providing routine project updates.
- Monitor and analyze manufacturing data as necessary to provide support for process improvement and investigations.
- Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
- Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
- Lead and ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.
- Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing) & work with vendors and suppliers to define requirements and understand functional specifications.
Candidate Requirements:
- Knowledge of data management tools and RCM.
- Bachelor’s degree or higher in chemical, electrical, or mechanical engineering, biochemistry, bioengineering, or related scientific field.
- 5+ years’ experience in biopharmaceutical or other GXP regulated industry.
- CMO/CDMO experience
- Technical and/or lean six sigma certifications