SOKOL GxP Services · 8 hours ago
Junior Validation Engineer
West Chester, PA
Contract
Onsite
New Grad, Entry Level
$35/hr - $45/hrSOKOL GxP Services is seeking a detail-oriented Validation Engineer to support validation and qualification activities within pharmaceutical and biotechnology environments. This role is responsible for executing and maintaining validation deliverables to ensure compliance with regulatory requirements and internal quality standards.
Pharmaceuticals
Responsibilities
Execute validation maintenance and requalification activities, including environmental/temperature mapping (temperature, RH, CO₂), autoclave loads, washer loads, and related documentation
Develop, execute, and maintain validation lifecycle deliverables (e.g., Validation Plans, URS, IQ/OQ/PQ, RTM, risk assessments, and summary reports)
Perform periodic reviews of computerized systems in accordance with defined schedules (every 1-3 years)
Review vendor qualification documentation and prepare summary reports as needed
Revise and maintain SOPs, forms, and work instructions in collaboration with stakeholders
Support QMS activities, including change control, deviations, and CAPA, and develop associated validation and SDLC deliverables
Conduct risk assessments, support issue investigations, and assess validation impact from change controls
Collaborate with Engineering, QA, Manufacturing, and vendors to maintain a compliant validated state
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field (or equivalent experience)
Experience supporting validation/qualification activities and documentation (e.g., IQ/OQ/PQ, validation maintenance)
Familiarity with GMP/GxP regulations and basic QMS processes (change control, deviations, CAPA)
Ability to review vendor documentation and support compliance assessments
Strong documentation, organizational, and communication skills
Comfortable working cross-functionally in a regulated environment
Preferred
Exposure to computerized systems and periodic reviews preferred
Benefits
Health, dental, and vision insurance (for eligible full-time employees)
401(k) plan with company match (for eligible full-time employees)
Paid time off and company holidays
Interest free relocation assistance loan
Per diem and paid lodging for travel assignments
Continuous professional development and training opportunities through SOKOL GxP Academy
Company
SOKOL GxP Services
SOKOL GxP delivers cost-effective Commissioning, Qualification, and Validation (CQV) services for pharmaceutical, biotech, and cell therapy companies.
Founded in 2012
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase