Consultant Aseptic Processing (Lyophilizer)
Job Description
Scope of Work Capital project support o Provide equipment startup and engineering support for flex fill line o Participate in routine meetings with equipment vendors and Stakeholders o Develop/Review commissioning project plan, project change control o Participate in Failure Mode Risk Assessments o Generate/Review/Revise User Requirement Specifications and Function Requirement Specifications o Review vendor documents including but not limited to design specifications, configuration specification, drawings, protocols, etc. o Generate/Review design specifications and commissioning protocols o Participate in FAT, SAT and Commissioning & Qualification testing o Lead/support deviation investigation Operation support o Provide engineering support for ongoing commercial filling activities.
Knowledge and Skills: Understands the compliance expectation for aseptic operation and design principals for aseptic processing equipment Understand the engineering design principles of process equipment, facilities and utilities Understand the automation concepts of control architecture, system integration, etc. Good communication and problem-solving skills
Qualifications
Education and Experience: 10+ years of relevant experience and a BS or BA or related fields. Has previous experience in biotech or pharmaceuticals industry. Has previous experience in isolator technology and aseptic operation equipment (e.g. filler, lyophilizer).
Additional Information
VALIDATION AND ENGINEERING GROUP, USA INC. IS AN EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER.