Sr. Validation Engineer

Responsibilities

• Perform pre- and post-validation verification on test equipment.
• Create and execute validation protocols, procedures, and final reports; perform validation projects.
• Perform peer review of validation reports.
• Learn and execute troubleshooting strategies in the field.
• Independently manage technical writing and documentation aspects of validation reports.
• Write and work with clients to resolve deviations.
• Maintain records of pertinent information for the project including project costs reconciliation.
• Relay opinions or interpretations of results to customer.
• Train validation team members.

Qualifications

• BA/BS in technical or science related field of study preferred.
• Candidates with an HSD/GED, technical training, or an Associate’s degree combined with mechanical aptitude or relevant industry experience considered.
• 5+ years of direct validation experience required.
• Experience with autoclave qualification and processes.
• Experience with validation of temperature-controlled units and temperature mapping.
• Experience with validation of sterilization processes (steam sterilizers, SIP).
• Experience with validation of GMP laboratory and manufacturing equipment and computerized systems.
• Calibration expertise (temperature, humidity, CO2, pressure, timer) is a plus.
• Ability to perform tasks with high standard of quality and accuracy.
• Spreadsheet and word processing applications experience, computer literacy.
• Strong written and verbal communication skills.
• Proficient with test instruments.
• ISO 9001, ISO 17025, GMP and GLP knowledge.