Commissioning, Qualification, and Validation Engineer

AST-posted 3 months ago
$90,000 - $140,000/Yr
Full-time • Mid Level
Tacoma, WA
51-100 employees
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AST is seeking a Commissioning, Qualification, and Validation (CQV) Engineer to join our Research and Development Team. The CQV Engineer will play an active role in spearheading and developing AST’s CQV initiatives and services. You will work cross functionally to contribute and execute AST’s strategic vision on products, services, and customer experiences. This role reports to the Principal CQV Engineer and is a full-time position that is located onsite in Tacoma, Washington. If the CQV Engineer position aligns with your goals and you share our passion for AST’s Mission, Vision, Purpose, Values and Key Behaviors, we want to hear from you.

  • Lead qualification and validation activities (IQ, OQ, PQ) for filling line isolators in compliance with regulatory standards and company procedures.
  • Develop, execute, and approve validation protocols, test scripts, and reports for equipment commissioning and performance verification.
  • Provide quality oversight and technical support during validation efforts, including reviewing and approving documentation such as URSs, P&IDs, specifications, and SOPs.
  • Collaborate with cross-functional teams (engineering, manufacturing, QA, regulatory) to ensure project alignment and compliance.
  • Perform risk assessments and troubleshooting issues during validation to minimize project delays.
  • Maintain accurate and detailed documentation within the electronic document management system for audit readiness.
  • Support the development of Validation Master Plans, Equipment Validation Reports, and Summary Reports.
  • Assist with resolution of deviations, change controls, and validation-related issues during equipment builds and installations.
  • Attend project meetings, contribute to SOP development, and perform additional duties as needed to support validation objectives.
  • B.S. or M.S. in Engineering (Industrial, Mechanical, Process, or Chemical) or a related technical discipline.
  • 5–8 years as a Validation Engineer in the pharmaceutical or medical device industry.
  • At least 4 years of hands-on experience commissioning, qualifying, and validating filling and isolator systems in biotech/pharma manufacturing environments.
  • Proficient in validation lifecycle documentation: URS, FRS, DS, IQ, OQ, PQ, PV, CSV, MVP, and more.
  • Solid understanding of cGxP principles, ISO 13485, ISO 14971, 21 CFR Part 820, and EU Annex 1.
  • Working knowledge of Computer Systems Validation (CSV) and quality systems such as Change Control, Non-Conformances, and Requalification.
  • Strong technical writing, presentation, and documentation skills.
  • Excellent analytical, problem-solving, time management, and decision-making capabilities.
  • Demonstrated ability to manage multiple projects, work independently, and support cross-functional teams.
  • Highly proficient in Microsoft Office tools (Word, Excel, PowerPoint).
  • Effective communication, leadership, and interpersonal skills with a focus on customer service and results.
  • Medical (HSA & PPO)
  • Dental
  • Vision
  • Long/Short term disability
  • HSA account with employer contribution
  • 401(K) (Traditional & Roth options) with up to 5% company match
  • Education Assistance
  • Paid Time Off (PTO)
  • Paid Holiday
  • Bonus potential
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