Process Engineering Manager

Job Description

Contract Duration :- temp to hire potential

Shift timings :- 8am-5pm

Hybrid - 3 days on-site, 2 days remote

Who You Are:

Minimum Qualifications:

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• Minimum of 7+ years’ experience in cGMP environment
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• Bachelor’s or Master’s degree Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science related field
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• 5+ years’ experience with process validation, Process Performance Qualification (PPQ) and / or Continued Process Verification (CPV)
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Preferred Qualifications:

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• 10+ years’ experience / subject matter expert (SME) level of understanding with manufacturing, process validation, Process Performance Qualification (PPQ), and Continued Process Verification (CPV)
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• 5+ years of hands on experience working directly with cell culture upstream operations (flask expansion, cell stacks, bioreactors, clarification), or downstream purification (TFF (UF/DF), automated chromatography skids (AKTA, XMO), and/or sterile filtration)
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• Ability to lead and influence teams/efforts and processes without direct authority
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• Critical thinking skills that translate into improved outcomes/outputs, and ability to effectively solve and derisk technical problems and form solutions/plans to mitigate issues
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• Familiarity with cGMP document control systems and general procedures
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• Excellent attention to detail, with superior documentation and organization skills
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• Excellent computer, verbal, and written communication skills, including strong technical writing ability and a demonstrated ability to communicate scientific ideas to a broader cross-functional (technical/non-technical) audience
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