Sorry, this listing is no longer accepting applications. Don’t worry, we have more awesome opportunities and internships for you.

Consultant Aseptic Processing (Lyophilizer)

Validation & Engineering Group

Consultant Aseptic Processing (Lyophilizer)

Los Angeles, CA
Full Time
Paid
  • Responsibilities

    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

    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.