Talent.com
Commissioning, Qualification, and Validation Engineer

Commissioning, Qualification, and Validation Engineer

ASTTacoma, WA, US
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
  • serp_jobs.filters_job_card.quick_apply
job_description.job_card.job_description

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.  What can I expect in this role?
  • 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.

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.
  • 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.
  • This is a full-time position based in Tacoma.
  • All benefits listed in this post are subject to change.  Powered by JazzHR
  • serp_jobs.job_alerts.create_a_job

    Validation Engineer • Tacoma, WA, US

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Consultant Engineer I - Seattle

    Consultant Engineer I - Seattle

    FMMAPLE VALLEY, Washington, United States
    serp_jobs.job_card.full_time
    FM is one of the world’s largest risk management and industrial property insurance organizations.With 76 office locations in over 60 countries worldwide, FM provides specialized property protection...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Operations Quality Engineer

    Operations Quality Engineer

    ComriseRedmond, WA, United States
    serp_jobs.job_card.full_time
    PM-2 : 00 AM Monday, Tuesday, Wednesday, Thursday, flex Friday as needed.This would be a singular Operations Quality Engineer, supporting our second shift. This would be a universal player conducting ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Experienced Lean Practitioner

    Experienced Lean Practitioner

    BoeingSeattle, WA, United States
    serp_jobs.job_card.permanent
    Job Description At Boeing, we innovate and collaborate to make the world a better place.We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive, wi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    Specialist – Quality & Continuous Improvement II

    Specialist – Quality & Continuous Improvement II

    IntelliPro Group Inc.Kent, WA, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Specialist – Quality & Continuous Improvement II Position Type : Contract, Potential to extend or convert to FTE based on performance and business needs. Kent, WA Salary Range / Rate : $40 / h...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Engineering Tech V (5220)

    Engineering Tech V (5220)

    Three Saints Bay, LLCKeyport, WA, US
    serp_jobs.job_card.full_time
    Three Saints Bay, LLC, and a Federal Government Contractor industry leader, is seeking an Engineering Tech V to provide logistics and technical support for the Naval Undersea Warfare Center (NUWC) ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Test Program Manager

    Senior Test Program Manager

    Blue OriginKent, WA, US
    serp_jobs.job_card.permanent
    Job Opportunity At Blue Origin.At Blue Origin, we envision millions of people living and working in space for the benefit of Earth. We're working to develop reusable, safe, and low-cost space vehicl...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Manager Quality Improvement - USFHP

    Manager Quality Improvement - USFHP

    Providence Health & ServicesRenton, WA, US
    serp_jobs.job_card.full_time
    This is the job title and description.Please focus on the core content of the job post.serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Silicon Test Engineer

    Senior Silicon Test Engineer

    ImpinjSeattle, WA, US
    serp_jobs.job_card.full_time
    Impinj is a leading RAIN RFID provider and Internet of Things pioneer.We're inventing ways to connect every thing to the Internet. With more than 100 billion items connected to date, and multipl...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    MES Recipe Engineer & Validation Specialist (Bothell)

    MES Recipe Engineer & Validation Specialist (Bothell)

    TSR Consulting Services, Inc.Bothell, WA, US
    serp_jobs.job_card.part_time
    Role : MES Engineer / Validation Speicalist.Job Type : Contract, W2 (NO C2C).Location : Bothell, WA (hybrid 50 / 50 split). Duration : 6 months to start, potential for extensions that would be multi-year.P...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Quality Manager

    Quality Manager

    Syntricate TechnologiesBellevue, WA, US
    serp_jobs.job_card.full_time
    Position : Quality Manager Duration : Contract Location : Bellevue, WA~OVERLAND PARK, KS JD Automation Test lead with 8 or more years of experience in Designing & developing automation frameworks for ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Operations Quality Engineer (Redmond)

    Operations Quality Engineer (Redmond)

    ComriseRedmond, WA, US
    serp_jobs.job_card.part_time
    PM-2 : 00 AM Monday, Tuesday, Wednesday, Thursday, flex Friday as needed.This would be a singular Operations Quality Engineer, supporting our second shift. This would be a universal player conducting ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    Simulation Test Engineer

    Simulation Test Engineer

    Wealth Recruitment, LLCSeattle, WA, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    In this role, you’ll play a key part in supporting simulation workflows by curating data, troubleshooting pipeline issues, and driving process improvements that enhance both quality and efficiency....serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    MES Recipe Engineer & Validation Specialist

    MES Recipe Engineer & Validation Specialist

    TSRBothell, WA, US
    serp_jobs.job_card.full_time
    Job Type : Contract, W2 (NO C2C).Location : Bothell, WA (hybrid 50 / 50 split).Duration : 6 months to start, potential for extensions that would be multi-year. Please note that this role requires experi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Experienced Lean Practitioner

    Experienced Lean Practitioner

    BOEINGSeattle, WA, United States
    serp_jobs.job_card.full_time +1
    At Boeing, we innovate and collaborate to make the world a better place.We’re committed to fostering an environment for every teammate that’s welcoming, respectful and inclusive, with great opportu...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Project Manager Data Quality - Redmond, WA

    Project Manager Data Quality - Redmond, WA

    StaffingRedmond, WA, US
    serp_jobs.job_card.full_time
    Position Type : 6 months + contract.Work Permit : USC / GC and EAD preferred, no visa sponsorship available for this job and no third party. Six Sigma Certification preferred.Strong and proven experienc...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Quality Manager

    Quality Manager

    HexcelKent, WA, US
    serp_jobs.job_card.permanent
    With our strong investment in research and development and our culture of continuous improvement, Hexcel is the industry leader in the manufacturing of advance composite materials, including carbon...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Project Coordinator - Testing Team

    Project Coordinator - Testing Team

    Apex SystemsBellevue, WA, US
    serp_jobs.job_card.full_time
    Project Coordinator II (Contract).Meta's International Testing Programs team is seeking a detail-oriented Project Coordinator II to plan, manage, and execute in-market functional testing for Meta's...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Quality Manager

    Quality Manager

    Diverse LynxBellevue, WA, US
    serp_jobs.job_card.full_time
    Hands-on experience with performance testing tools (e.Strong knowledge of system architecture (web, cloud, microservices, databases). Proficiency in monitoring and APM tools (e.Dynatrace, AppDynamic...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30