Experienced Cleanroom Certification Specialist

4 days ago

Minneapolis, Minnesota, United States Pace Life Sciences Full time
About Us

Pace Life Sciences is a leading provider of critical equipment support services, advancing the science of pharmaceutical and biopharmaceutical customers through the drug development process.

Job Description

We are seeking a highly skilled Cleanroom Certification Specialist to join our Technical Field Services team. As a key member of our team, you will be responsible for performing equipment qualification services and cleanroom certification testing in diverse settings, building strong customer partnerships, and exceeding their needs.

Key Responsibilities:

  • Perform on-site testing and report completion of custom Installation, Operation, and Performance Qualification protocols for equipment, including the use of Kaye Validator systems.
  • Provide on-site testing of production cleanrooms, including HEPA integrity testing and ISO 14644 particle count certifications.
  • Provide on-site equipment certification, including laminar flow workstation, fume hood, and biological safety cabinet certification.
  • Manage enterprise software data management and prepare GMP-compliant test reports.
  • Develop custom Installation, Operation, and Performance Qualification protocols for equipment, including HVAC and cleanroom facilities, purified water systems, compressed air and gas systems, autoclaves, ovens, and other controlled environment equipment.

Requirements:

  • Relevant experience working with GMP critical utilities or in cleanroom certification, metrology, or other related testing or technical tasks.
  • Ability to understand technical drawings and manuals.
  • Strong technical aptitude, as demonstrated through work or educational experience.
  • CETA certification, preferred.
  • Ability to extract technical requirements from various sources and create executable protocols from the technical requirements.
  • Exceptional customer service skills.
  • Physical ability to work in active construction zones.
  • Valid driver's license required.
  • Up to 25% travel nationally.
  • Computer skills, MS Office, and specialized programs.
  • Excellent MS Word formatting ability.
  • Good team interaction personality.
  • High School diploma minimum, some college or technical education helpful.
  • Technical writing ability.
  • Basic math skills, including geometry and algebra.
  • Ability to work in a self-directed environment.

What We Offer:

  • Comprehensive benefit program, including medical, vision, and dental insurance, 401(k) matching, and a tuition reimbursement program.
  • Opportunities to build a rewarding career.
  • An inclusive culture that stands for integrity, innovation, and growth.

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