EXPANSION Validation Specialist
On-siteLexington, Kentucky, United States
Job Summary
Execute validation and qualification protocols for manufacturing, packaging, laboratory, utility systems, and equipment in accordance with cGMPs, GEPs, and change control. Write, schedule, plan, and manage these protocols while acting as the technical interface for on-site validation activities with third parties. Coordinate with Operations, Technical Services, Facility Engineering, Microbiology, and Quality Assurance to lead qualification timelines and manage equipment requirements. Independently design studies, develop documents including User Requirement Specifications, Design Qualifications, Commissioning plans, and risk assessments, and author Standard Operating Procedures. Lead investigations for validation discrepancies, implement corrective actions, and conduct periodic reviews of facilities and sterilization cycles.
Required Qualifications
- Bachelor's Degree in the physical or biological sciences or engineering
- 2+ years of QA and/or Regulatory experience in a cGMP/FDA regulated environment
- Thorough knowledge of cGMP (Current Good Manufacturing Practice) regulations, guidance, and general compliance expectations
- Technical writing skills
- In-depth understanding of investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writing
- Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP)
- Thorough understanding of Common Technical Document (primarily Chemistry and Manufacturing Controls (CMC) format, content, and filing requirements for US and EU
- High level of proficiency operating all Microsoft Office applications
- Excellent communication skills, both verbally and in writing
- Detail oriented and organized
Desired Qualifications
- Sterile manufacturing of injectables strongly preferred
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.