Validation Engineer

3 weeks ago

Los Angeles, California, United States PSC Biotech Full time
Job Summary

PSC Biotech is seeking a highly skilled Validation Engineer to support the commissioning, qualification, and validation of equipment and systems in the pharmaceutical manufacturing and biotech environments. The ideal candidate will have a strong understanding of regulatory requirements and industry standards, as well as excellent problem-solving and analytical skills.

Key Responsibilities
  • Develop and execute validation protocols (IQ, OQ, PQ) for required equipment, processes, and systems.
  • Write, review, and/or author all required validation documentation, including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, URS, FRS, and so on.
  • Collaborate with cross-functional teams to ensure validation activities are aligned with project timelines and regulatory requirements.
  • Conduct risk assessments and validation impact assessments. Investigate and resolve validation-related issues and deviations.
  • Analyze test results data and acceptance criteria to ensure accuracy.
  • Additional responsibilities as required to drive project deliverables.
Requirements
  • Bachelor's degree in a related engineering discipline.
  • 15 years of experience executing commissioning, qualification, and validation for a range of equipment and systems within the pharmaceutical and/or biotechnology industries.
  • Experienced writing and generating technical validation documentation, including IQ/OQPQ protocols, reports, procedures, etc.
  • Knowledge of regulatory requirements and industry standards (cGMP, FDA, etc.).
  • Strong understanding of risk-based validation approach.
  • Proactive and motivated with the ability to manage multiple tasks/projects.
  • Excellent problem-solving, analytical, and technical skills.
  • Strong time management and organizational abilities.
  • Effective communication and interpersonal skills.
  • Detail-oriented mindset with a commitment to maintaining high-quality standards.
  • Ability to work independently and as part of a team.
Benefits

PSC Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and education assistance. We are committed to providing a supportive and inclusive work environment that promotes work-life balance and career growth.

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