Process Engineer (100% Travel)
Skills
- Practical knowledge of cGMP and cGxP quality systems in FDA-regulated manufacturing.
- Experience with commissioning, qualification, CQV, and technology transfer activities.
- Familiarity with laboratory and manufacturing systems such as LIMS and MES.
- Hands-on experience with fillers, wave bioreactors, cell processing systems, scales, pumps, welders/sealers, and flow cytometers.
- Proficiency with MS Office, MS Project, and Visio.
- Strong verbal and written communication, problem-solving, and client-facing skills.
- Ability and willingness to travel frequently to client sites across the U.S.
Responsibilities
- Develop and review requirements specifications, design, and functional requirements for process equipment and systems.
- Lead or support commissioning, qualification, and start-up activities for facilities, utilities, and equipment (FUE).
- Support technology transfer and scale-up from development to commercial manufacturing.
- Perform risk assessments, feasibility reviews, and testing of process materials and mitigations.
- Provide technical support for product/process lifecycle, MSAT, and engineering projects at vendor or third-party sites.
- Recommend and implement process and technology improvements to increase quality and efficiency.
- Facilitate meetings with subject matter experts and coordinate cross-functional project activities.
- Ensure compliance with cGMP, FDA guidance, and industry standards.
Education
- Bachelor’s degree in Engineering, Bio/Pharma Science, or related technical field required.
- Master’s degree in engineering or related field preferred but not required.
Benefits
- Market-competitive base salary with annual incentive plan
- Robust health, dental, and vision benefits
- Flexible paid time off and company-paid holidays
- Remote work flexibility and ability to work almost anywhere
- Professional development, recognition programs, and career growth opportunities
- Award-winning workplace culture and employee support programs
Average salary estimate
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