AST
Commissioning, Qualification, and Validation Engineer
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Commissioning, Qualification, and Validation Engineer
role at
AST . This is a full-time onsite position located in Tacoma, Washington. AST is an equal opportunity employer. Overview
AST is seeking a Commissioning, Qualification, and Validation (CQV) Engineer to join our Research and Development Team. The CQV Engineer will lead and develop AST’s CQV initiatives and services, working cross-functionally to contribute to AST’s strategic vision on products, services, and customer experiences. This position reports to the Principal CQV Engineer and is located onsite in Tacoma, WA. Role accountabilities (Responsibilities)
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 troubleshoot 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. Travel is anticipated at >50% of the time. 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. Ability to manage multiple projects, work independently, and support cross-functional teams. Proficiency with 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. Compensation & Benefits
Compensation range for onsite WA applicants is $90,000 to $140,000. 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. Location & Employment
This is a full-time position based in Tacoma, Washington. 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.
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Join to apply for the
Commissioning, Qualification, and Validation Engineer
role at
AST . This is a full-time onsite position located in Tacoma, Washington. AST is an equal opportunity employer. Overview
AST is seeking a Commissioning, Qualification, and Validation (CQV) Engineer to join our Research and Development Team. The CQV Engineer will lead and develop AST’s CQV initiatives and services, working cross-functionally to contribute to AST’s strategic vision on products, services, and customer experiences. This position reports to the Principal CQV Engineer and is located onsite in Tacoma, WA. Role accountabilities (Responsibilities)
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 troubleshoot 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. Travel is anticipated at >50% of the time. 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. Ability to manage multiple projects, work independently, and support cross-functional teams. Proficiency with 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. Compensation & Benefits
Compensation range for onsite WA applicants is $90,000 to $140,000. 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. Location & Employment
This is a full-time position based in Tacoma, Washington. 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.
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