QA Validation Engineer

• Serve as a key Quality point of contact for facilities, utilities, and production/support equipment
• Collaborate with Engineering, Manufacturing, and QA Ops on day-to-day and project work
• Review and approve IQ/OQ/PQ protocols and reports for manufacturing and analytical equipment (including software/computerized systems)
• Ensure qualification activities comply with cGMP, GAMP 5, and internal standards
• Provide QA input into technology transfer and PPQ activities as processes move into or scale within the site
• Verify that new or modified processes are appropriately assessed, validated, and documented
• Lead or support deviations related to equipment, facilities, and engineering events
• Perform or oversee root cause analysis and define practical, effective CAPAs
• Draft and revise SOPs, technical work instructions, and validation/engineering documentation
• Help streamline processes and close gaps as the site matures
• Participate in or facilitate risk assessments (e.g., FMEA) for new equipment, changes, and processes
• Recommend controls to reduce impact to product quality and patient safety

• ~5+ years in Quality Engineering, Validation, or a similar technical Quality role in a biotech/biopharma cGMP environment, + Strong understanding of cGMP and validation lifecycle concepts
• Familiarity with GAMP 5 and computerized system expectations
• Hands-on exposure to equipment and/or facility qualification, change control, deviations, and CAPA

• Collaboration skills: *

• Comfortable working cross-functionally and communicating with Engineering, Manufacturing, and QA at all levels

Preferred Extras

• Background in gene therapy, cell therapy, viral vectors, biologics, or sterile/aseptic manufacturing
• Experience supporting new site startup, facility expansion, or tech transfer projects
• Prior work in a fast-paced, small or mid-size biotech environment, * Full-time role, primarily standard business hours with some flexibility based on project and qualification activities

Technical Source is looking for a QA Validation Engineer for our pharmaceutical manufacturing client in Raleigh Durham, NC who will work cross functionally with Quality, Engineering, and Manufacturing, with a strong focus on equipment, facilities, and process performance under cGMP.