Job Description

​ The successful Senior Process Engineer will be a member of the Operations Team and is responsible for providing technical support and project support to Operations, Facilities Engineering, Product Development, Quality, and Regulatory Affairs.  This position will focus on introduction of new technologies with the goal of improving and optimizing operations and capital project support.   This includes but is not limited to creating budgets and managing external resources.  Knowledge of cGMPs and experience with GMP manufacturing is essential.

• Lead new technology projects to optimize manufacturing processes.
• Lead and/ or participate in technology transfer within the company and to partners.
• Support GMP audits from regulatory agencies as well as internal audits.
• Lead and/or support Capital Project work
• Lead and/ or
• participate in cross functional teams dedicated to process improvement, efficiency, and optimization.
• Provide technical assessments for investigations, validation, and change control
• Execute studies and comparability protocols for manufacturing operations.
• Generate and revise control documents to support process equipment and manufacturing processes.

Qualifications

• Minimum 15 years of relevant cGMP and technical experience
• BS degree in technical fields such as Engineering, Biology, Chemistry
• Knowledge of process equipment design
• Experience with CIP/SIP and start-ups preferred.
• Experience with pilot-scale pharmaceutical/ biopharmaceutical process equipment
• Ability to solve issues through DOE.

Additional Information

NO! AGENCIES OR 3RD PARTY AGENCIES.  WE DO NOT WORK THROUGH OTHER EMPLOYERS

THIS IS A PERM ROLE DIRECTLY WITH OUR CLIENT.

Please attach a WORD resume to your submission

All of your information will be kept confidential according to EEO guidelines. EOE/Veteran/Disabled