Junior Validation Engineer

SOKOL GxP Services • West Chester, PA

9h • $35 - $45

About The Position

SOKOL 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.

Requirements

• 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)
• Strong documentation, organizational, and communication skills
• Comfortable working cross-functionally in a regulated environment

Nice To Haves

• Exposure to computerized systems and periodic reviews preferred
• Ability to review vendor documentation and support compliance assessments

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level