Process Engineering Manager

Contract Duration :- temp to hire potential

Shift timings :- 8am-5pm

Hybrid - 3 days on-site, 2 days remote

Who You Are:

Minimum Qualifications:

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

Preferred Qualifications:

• 10+ years’ experience / subject matter expert (SME) level of understanding with manufacturing, process validation, Process Performance Qualification (PPQ), and Continued Process Verification (CPV)
• 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)
• Ability to lead and influence teams/efforts and processes without direct authority
• 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
• Familiarity with cGMP document control systems and general procedures
• Excellent attention to detail, with superior documentation and organization skills
• 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