Validation Engineer II

Tolmar-posted 3 months ago
$87,000 - $95,000/Yr
Full-time • Mid Level
Windsor, CO
Chemical Manufacturing
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The Validation Engineer II is responsible for independently planning, executing, and documenting validation activities in a sterile injectable manufacturing environment. Responsibilities include equipment, facilities, utilities, cleaning and process validation, all in compliance with cGMP, FDA, EU, and other regulatory requirements.

  • Plan and coordinate validation activities for cross-functional projects, including but not limited to validation plans, protocols, and reports.
  • Develop and execute validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities, and processes.
  • Lead cleaning and sterilization validation activities, including autoclaves and SIP systems.
  • Conduct risk assessments (e.g., FMEA) and support change control evaluations.
  • Analyze validation data, prepare comprehensive reports, and ensure audit readiness.
  • Collaborate with cross-functional teams, including QA, Manufacturing, Engineering, and Quality Control.
  • Maintain validation lifecycle documentation in accordance with internal procedures and regulatory expectations.
  • Provide validation guidance and support to teams in developing and executing protocols.
  • Support investigations and CAPAs related to validation deviations or failures.
  • Contribute to continuous improvement initiatives in validation practices.
  • Stay current with industry trends, regulatory updates, and best practices in validation and sterility assurance.
  • Participate in required annual hazardous waste training.
  • Respond to spills per the Chemical Spill Procedures.
  • Perform other related duties as assigned.
  • Bachelor's degree in Engineering, Life Sciences, or a related technical field.
  • Minimum of 2 years' experience in validation, preferably in a sterile pharmaceutical or biotech environment.
  • Strong understanding of cGMP, FDA, and EU regulatory requirements.
  • Proficient in Microsoft Office Suite.
  • Knowledge of GMP regulations and validation guidelines.
  • Strong technical writing and documentation skills.
  • Excellent oral and written communication skills.
  • Effective organizational and project management skills.
  • Effective troubleshooting and problem-solving skills.
  • Ability to maintain gowning requirements for controlled areas.
  • Ability to manage multiple projects simultaneously.
  • Ability to work both independently and as part of a team.
  • Ability to develop and implement creative solutions to problems.
  • Familiarity with aseptic processing, cleanroom classifications, and environmental monitoring preferred.
  • Experience with validation software or electronic document management systems preferred.
  • Pay: $87,000 - $95,000
  • Equitable, fair pay practices including market-based base pay and a strong benefits package.
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