Validation Engineer

Bothell, WI, US • Posted 3 days ago • Updated 4 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • Test Scripts
  • GMP
  • Collaboration
  • Quality Assurance
  • Manufacturing Engineering
  • GxP
  • Data Integrity
  • Regulatory Compliance
  • Science
  • Pharmaceutics
  • Life Sciences
  • IQ
  • OQ
  • PQ
  • Computerized System Validation
  • Good Manufacturing Practice
  • GAMP
  • Corrective And Preventive Action
  • Risk Assessment
  • Documentation
  • Analytical Skill
  • Conflict Resolution
  • Problem Solving
  • Communication
  • Manufacturing
  • Management
  • Trackwise
  • Veeva
  • Master Control
  • Auditing

Summary

Summary :

We are seeking an experienced Validation Engineer to support pharmaceutical manufacturing and quality operations in Washington. The ideal candidate will have hands-on experience in equipment, process, cleaning, and computerized system validation within a GMP-regulated pharmaceutical environment. This role requires strong knowledge of validation lifecycle activities, regulatory compliance, documentation, and cross-functional collaboration.

Roles & Responsibilities :
  • Execute and support validation lifecycle activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Develop, review, and approve validation protocols, test scripts, summary reports, and related GMP documentation.
  • Perform equipment qualification for manufacturing, packaging, utilities, and laboratory systems.
  • Support process validation, cleaning validation, and revalidation activities for pharmaceutical manufacturing processes.
  • Conduct impact assessments for change controls, deviations, CAPA, and non-conformance investigations.
  • Collaborate with Quality Assurance, Manufacturing, Engineering, and Regulatory teams to ensure compliance with validation requirements.
  • Ensure validation documentation aligns with FDA, cGMP, GxP, 21 CFR Part 11, and data integrity requirements.
  • Participate in commissioning and qualification activities for new equipment and facility expansions.
  • Review calibration, maintenance, and qualification records for compliance readiness.
  • Support internal/external audits and regulatory inspections by providing validation documentation and technical expertise.
  • Maintain validation master plans, SOPs, and validation schedules.

Education & Experience :
  • Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related field.
  • 5+ years of validation experience in pharmaceutical, biotech, or life sciences industry.
  • Strong experience in IQ/OQ/PQ, process validation, cleaning validation, CSV, and equipment qualification.
  • Knowledge of FDA regulations, cGMP, GAMP 5, 21 CFR Part 11, ALCOA+, and validation lifecycle methodologies.
  • Experience with deviations, CAPA, change controls, and risk assessments.
  • Excellent documentation, analytical, and problem-solving skills.
  • Strong communication skills and ability to work cross-functionally in a fast-paced environment.
  • Experience with sterile manufacturing, aseptic processing, or biologics is a plus.
  • Familiarity with validation management systems such as TrackWise, Veeva, Kneat, MasterControl, or ValGenesis.
  • Prior experience supporting regulatory inspections or audit readiness initiatives.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 9b529ba0d6cd22dcc6bee5d3a2f51475
  • Posted 3 days ago
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