What are the responsibilities and job description for the Validation Engineer position at Katalyst Healthcares and Lifesciences?
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 :
Education & Experience :
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.