Validation Engineer

Stryker Corporation; Northern (KY); Hybrid; Confidential; Full time

Job summary

Stryker Corporation is seeking an experienced Validation Engineer to support pharmaceutical manufacturing and quality operations, focusing on IQ/OQ/PQ, process and cleaning validation, and CSV within a GMP-regulated setting.

The role requires strong documentation, analytical skills, and collaboration across Quality Assurance, Manufacturing, Engineering, and Regulatory teams to ensure FDA and cGMP compliance and data integrity. Sterile or biologics experience is a plus.

Qualifications

• 5+ years of validation experience in pharma/biotech or life sciences.
• Experience with 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 cross-functional collaboration in fast-paced environments.
• Experience with sterile manufacturing, aseptic processing, or biologics is a plus.
• Familiarity with validation management systems: TrackWise, Veeva, Kneat, MasterControl, ValGenesis.

Responsibilities

• Execute validation lifecycle activities including IQ, OQ, and PQ.
• Develop, review, and approve validation protocols, test scripts, and reports.
• Qualify manufacturing, packaging, utilities, and laboratory equipment.
• Support process and cleaning validation and revalidation activities.
• Conduct impact assessments for change controls, deviations, CAPA, and non-conformance investigations.
• Collaborate with QA, Manufacturing, Engineering, and Regulatory teams.
• Ensure validation documents meet FDA, cGMP, GxP, 21 CFR Part 11 and data integrity.
• Participate in commissioning and qualification for new equipment and facility expansions.
• Review calibration and qualification records for compliance readiness.
• Support audits and regulatory inspections with validation documentation.
• Maintain validation master plans, SOPs, and validation schedules.

Skills

Validation expertise

IQ/OQ/PQ

Regulatory compliance

Documentation

Cross-functional collab

Analytical problem-solving

Communication

Education

Bachelor's degree in Engineering/Life Sciences

Tools

TrackWise

Veeva

Kneat

MasterControl

ValGenesis

Job description

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-functional 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.