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AST · 3 months ago

Commissioning, Qualification, and Validation Engineer

Tacoma, WA

Full-time

Onsite

Mid, Senior Level

$90K/yr - $140K/yr

5+ years exp

AST is a company that enhances the efficiency, productivity, and safety of aseptic manufacturing processes for the Life Science Industry. They are seeking a Commissioning, Qualification, and Validation (CQV) Engineer to lead qualification and validation activities, develop validation protocols, and collaborate with cross-functional teams to ensure compliance and project alignment.

BiotechnologyConsumer ElectronicsHealth CareInformation TechnologyManufacturingPharmaceuticalRobotics

Comp. & Benefits

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 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

Qualification

Validation Engineer experienceCommissioningQualificationValidation lifecycle documentationCGxP principles knowledgeComputer Systems ValidationMicrosoft Office proficiencyTechnical writing skillsAnalytical skillsCustomer service focusProblem-solving skillsTime managementDecision-making capabilitiesLeadership skillsInterpersonal skills

Required

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

Must be legally authorized to work in the United States without restriction

Must be willing to take and successfully pass a drug test