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Senior Validation Engineer

2 months ago

Broomfield, Colorado, United States GBA Full time
Senior Validation Engineer

COMPI is a leading engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device, and laboratory facilities.

Key Responsibilities:
  • Support client commissioning/validation for facility, utility, equipment, cleaning, and process validation projects
  • Prepare and execute commissioning/validation lifecycle documents
  • Participate in clinical or commercial production, including green field construction, facility renovation, new product development, product launch, or product/process upgrade
  • Write summary reports for validation and qualification protocols
  • Support project milestones, priorities, and deadlines
  • Write operating procedures for technical equipment and practices
  • Perform system and process risk assessments and analyses
  • Schedule and coordinate protocol execution with other departments
  • Develop project-specific validation plans and strategy
Requirements:
  • Bachelor's degree in a related life sciences or requisite industry training and experience
  • 5-10 years GMP experience
  • Aseptic process experience preferred
  • Critical utility experience preferred
  • Ability to converse about scientific matters
  • Ability to work independently or in collaboration with others
  • In-depth understanding and application of validation principles, concepts, practices, and standards
  • Proficient in current Good Manufacturing Practices and other applicable regulations
  • Experienced with all pertinent industry best practices (e.g., ISPE)

Salary range is $85-175K, depending on experience level. On-the-job training will be provided by the validation team and manager, and through industry training and certification courses, both online and in person.

All candidates must be legally eligible to work in the United States. Just be willing to travel regionally and/or nationally throughout the U.S.

We are an equal opportunity employer M/F/D/V

COMPI does not accept unsolicited resumes from recruiters/third parties