Remote- und Homeoffice Jobs in west-chester ∙ Seite 13

Description

SOKOL GxP Services is seeking an experienced and detail-oriented Validation Engineer to support temperature and environmental mapping activities for GMP-controlled spaces, equipment, and utilities, while also contributing to general Commissioning, Qualification, and Validation (CQV) activities. Responsibilities include planning, execution, and documentation of temperature and relative humidity (RH) mapping studies using calibrated sensor systems (e.g., Ellab), as well as supporting standard CQV lifecycle deliverables to maintain a compliant validated state.

Key Responsibilities

• Execute validation maintenance and requalification activities, including temperature, RH, and CO₂ mapping; autoclave and washer load qualifications; and associated documentation
• Plan and perform temperature and RH mapping studies for controlled rooms, warehouses, incubators, refrigerators, freezers, and other temperature-controlled units using calibrated sensors/data loggers (e.g., Ellab)
• Configure, deploy, verify calibration/placement, retrieve sensors, and perform data download, integrity checks, analysis, and reporting of mapping results, including identification of hot/cold spots and excursions
• Develop, execute, and maintain validation lifecycle deliverables (e.g., Validation Plans, URS, IQ/OQ/PQ, RTM, risk assessments, summary and mapping reports)
• Support periodic reviews of computerized systems per defined schedules (every 1–3 years) and review vendor qualification documentation as needed
• Revise and maintain SOPs, forms, and work instructions in collaboration with stakeholders
• Support QMS activities, including change control, deviations, and CAPA, and assess validation impact of changes
• Collaborate with QA, Engineering, Facilities, Manufacturing, and vendors to maintain a compliant validated state

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience)
• Hands-on experience with temperature and environmental mapping (temperature, RH, CO₂), including use of data loggers/sensor systems (e.g., Ellab or equivalent)
• 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)
• Exposure to computerized systems and periodic reviews preferred
• Ability to review vendor documentation and support compliance assessments
• Strong documentation, organizational, and communication skills
• Comfortable working cross-functionally in a regulated environment

Benefits

• $35 - $45 an hour
• 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