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14 days ago
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validation gmp fmea microbiology capa

📋 Description

  • Lead and execute Process Hygiene activities across Biologics Manufacturing, covering Central
  • Serve as the Process Hygiene subject matter expert for Manufacturing operations, translating
  • Provide technical leadership for contamination control, aseptic practices, Product Change Overs
  • Lead and execute contamination and cross-contamination FMEAs, operability studies, Product Change
  • Lead and provide subject matter expertise for process-hygiene related investigations including
  • Drive process hygiene initiatives and projects, including contamination risk-reduction

🎯 Requirements

  • Bachelor’s degree in Microbiology, Biology, Biotechnology, Chemical Engineering, Pharmacy, or a
  • Minimum 7 years of relevant experience in biologics/pharmaceutical manufacturing, aseptic
  • Hands-on knowledge of cGMP, contamination control, aseptic techniques, quality systems
  • Experience conducting FMEAs, operability/risk assessments, data trending and shop-floor/Gemba
  • Demonstrated ability to lead technical initiatives and cross-functional teams without direct
  • Strong technical writing, training, coaching, facilitation and stakeholder-communication skills
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