Validation Engineer

3 weeks ago

Philadelphia, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Support all aspects of the Cleaning Validation Life Cycle for clients from development through qualification and monitoring .
  • Create/author/execute at a minimum , Validation Plans, V-cycle documents, Validation Summary Report, Qualification protocols/reports, and Performance Qualification protocols/reports.
  • Responsible for the qualification of cleaning manufacturing equipment independently in aseptic filling and GMP areas, including autoclave, Vessel Equipment validation, Sterilization in Place of filling vessels and COP validation in accordance with corporate and departmental procedures.
  • Participate i n cross-functional project team , including value streams and site support groups to address specific problems, facilitate discussion and research and enable procedures to become more efficient.
  • Experience with writing and executing Hold Time studies.
  • Experience with gowning in aseptic classified areas.
  • Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, and standard operating procedures.
  • Perform carry-over calculations and determine cleaning limits. Must have demonstrated self-direct work habits and strong communication skills.
  • Must be a committed team player prepared to work in and embrace a team-based culture.
  • Familiarity with regulatory expectations regarding electronic records and electronic signatures.
  • bility to work in a high complex matrix environment.
  • Sense of urgency, flexibility and accountability.
  • bility to follow written procedures and document results in a neat and precise manner , following Good Documentation Practices .
  • Maintain attention to detail, while completing multiple or repetitive tasks.
  • Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
  • Maintain a high level of integrity while balancing multiple priorities and responsibilities.
Requirements:
  • BS in science or engineering.
  • Minimum of 5 years pharmaceutical/biotech experience in validation with knowledge .
  • Proficient and experience with Kaye validators and temperature data loggers to independently perform temperature mapping studies for autoclave and Vessel SIP
  • Proficient and experience with sampling for cleaning validation including independently performing swabbing and taking rinse samples.
  • Prior experience preparing and executing equipment qualification documents required.
  • SME experience in the following areas is preferred :
  • Sterilization Validation (autoclave and vessel SIP)

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