Senior Validation Engineer

. Develop strategy, establish acceptance criteria, and generate and execute cleaning validation protocols and reports .

Posted 9/25/2026full-timeSan Diego • California • United StatesSenior💰 $103,939 - $166,204 per yearWebsite

Key responsibilities & impact

Develop strategy, establish acceptance criteria, and generate and execute cleaning validation protocols and reports
Perform, coordinate, execute, and analyze cleaning recovery studies
Lead cross-functional project teams to address issues and ensure timely completion of qualification and validation deliverables
Provide qualification and validation guidance and strategy during project planning and development phases
Train, coach, and mentor Quality Engineer I and II
Write validation protocols and final reports, test methods, standard operating procedures, and technical reports
Plan, write, and execute DQ, IQ, OQ, and PQ qualification protocols and reports
Independently conduct and document investigations related to validation studies
Evaluate validation studies and recommend improvements to operations, processes, and methods
Ensure the accuracy and validity of testing results
Support and assist with inspections and audits
Plan and perform periodic re-validation and re-qualification activities
Communicate with associates across the company to ensure timely completion of tasks and projects
Adhere to cGMP and safety procedures and contribute to GMP systems improvements
Perform other related duties as assigned

What you’ll need

Bachelor's degree in science discipline (chemistry, biochemistry, organic chemistry, biology, microbiology, chemical engineering or equivalent)
5+ years of Commissioning, Qualification and Validation (CQV) experience in a GMP/GDP environment
Experience with planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports
Experience with validation / monitoring of critical pharmaceutical utility systems, including purified water, nitrogen systems and cold storage units
Experience with planning and execution of cleaning validation of production lab glassware and equipment, including validation studies, protocols, reports, technical documents, and validation-related investigations (preferred)
Experience with developing coupon spike and recovery studies for cleaning validation
Experience with Lean Six Sigma methods, including root cause analysis and failure mode analysis
Understanding of cleaning validation requirements for the pharmaceutical industry
Knowledge of and ability to perform MAC calculation for APIs
Understanding of GMP for Active Pharmaceutical Ingredients per ICH Q7
Knowledge of chemical composition, structure, properties, chemical processes and transformations, chemical interactions, danger signs, production techniques, and disposal methods
General lab instrumentation knowledge and operation experience
Capable of working methodically and adhering to rules and regulations
Master's degree in a science-related field (preferred)

Comp & perks