Process Engineering Manager

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