Commissioning, Qualification, And Validation Engineer

Commissioning, Qualification, And Validation (Cqv) Engineer

At AST, we enhance the efficiency, productivity, and safety of flexible aseptic manufacturing processes for the worldwide Life Science Industry by offering innovative products, services, and solutions. Do you want to contribute to a shared vision and mission? Would you like to bring your unique talents to have a significant impact at a growing company? At AST we strive to build a workplace that enables every team member to meet and exceed their capabilities. We set our expectations high and provide the environment and resources necessary to bring out the very best. AST is proud of our team. Providing challenging and rewarding work, with opportunities for personal/professional development is our key to this longevity. AST is an equal opportunity employer.

Compensation range for onsite WA applicants is $90,000 to $140,000. All applicants are welcome to apply. Employee benefits include: 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, and bonus potential.

Role Accountabilities:

• 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.
• 50% travel required.

Qualifications:

• 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.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take and successfully pass a drug test.

This is a full-time position based in Tacoma.