Validation Engineer II
About The Position
The Validation Engineer II performs validation equipment preparation, protocol execution, and final report generation. The role focuses on validation activities for environmental chambers and related equipment, including cryo-freezers, cold rooms, refrigerators, incubators, depyrogenation ovens, stability chambers, warehouses, sterilizers, and computer systems validation (CSV). The engineer interfaces with customers and equipment end users, works with minimal supervision, and independently supports small and medium projects at customer sites. This is a 100% on-site position with significant travel, including daytime travel to client sites and possible overnight stays. The regular schedule is 1st shift, Monday through Friday, 8:00 a.m. to 4:30 p.m.; occasional off-shift or weekend coverage may be needed to meet schedules or project timelines. The role includes frequent work in an office, laboratory, or at customer sites, with exposure to environmental and workplace conditions described in the physical demands section. The base hourly pay range is $38.00–$47.00.
Requirements
- Minimum of two years of direct validation experience.
- Experience validating temperature-controlled units and performing temperature mapping.
- Ability to perform tasks to a high standard of quality and accuracy.
- Experience with spreadsheet and word-processing applications and general computer literacy.
- Strong written and verbal communication skills.
- Proficiency with test instruments.
- Knowledge of ISO 9001, ISO 17025, GMP, and GLP.
- Bachelor’s degree in a technical or science-related field; candidates with an HSD/GED, technical training, or an associate degree may qualify when combined with mechanical aptitude or relevant industry experience.
Responsibilities
- Perform pre- and post-validation verification on test equipment.
- Perform calibrations incidental to validation, including controllers, gauges, and recorders.
- Create and execute validation protocols and procedures, generate final reports, and perform validation projects.
- Perform peer review of validation reports.
- Learn and execute troubleshooting strategies in the field.
- Independently manage technical writing and documentation for validation reports.
- Write and work with clients to resolve deviations.
- Maintain pertinent project records, including project-cost reconciliation.
- Relay opinions or interpretations of results to customers.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
