Senior Commissioning Engineer

2 weeks ago


Pomona, California, United States PSC Biotech Full time
About the Role

PSC Biotech is seeking a highly skilled Commissioning Engineer to join our team. As a key member of our operations team, you will be responsible for ensuring that our facilities and equipment meet the highest standards of quality and regulatory compliance.

Key Responsibilities
  • Develop and execute commissioning, qualification, and validation protocols for equipment and systems.
  • Schedule and execute qualification activities, ensuring timely completion and compliance with industry standards.
  • Prepare and deploy validation documentation, including IQ/OQ/PQ protocols, reports, and operating procedures.
  • Document and report validation activities and results, ensuring accurate and up-to-date records.
  • Perform risk assessments and develop mitigation strategies for equipment and processes.
  • Analyze test results and data to ensure accuracy and compliance.
  • Collaborate with cross-functional teams to ensure successful project execution and alignment with company goals.
Requirements
  • Bachelor's degree in a related engineering discipline.
  • 3-5 years of commissioning, qualification, and validation experience in the pharmaceutical manufacturing industry.
  • Hands-on experience with IQ, OQ, PQ execution, including equipment like chambers, refrigerators, and fill lines.
  • Strong knowledge of aseptic processes and techniques.
  • Excellent technical writing skills and experience with full life cycle validation documentation.
  • Excellent communication and interpersonal skills.
  • Ability to travel for project assignments and client engagements.
What We Offer
  • Competitive salary range: $80,000-$100,000 per year.
  • Comprehensive benefits package, including medical, dental, and vision insurance.
  • 401(k) and 401(k) matching.
  • PTO, sick time, and paid holidays.
  • Education assistance.
  • Pet insurance.
  • Fitness benefits and discounts.
  • Financial perks and discounts.
Equal Opportunity Employment Statement

PSC Biotech is committed to a policy of Equal Employment Opportunity and prohibits discrimination against qualified employees, interns, and applicants in all aspects of employment.



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