Validation Engineer – GMP Cleaning & CQV Lead

Bachem; Vista (CA); On-site; USD 104,000 - 143,000; Full time

Benefits offered by this job

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation and sick days

Job summary

Bachem Americas in California is seeking a Quality Engineer (QE) / Validation to support cleaning validation activities for API and PMO manufacturing, plus qualification of equipment, facilities, and utilities. This role partners with Manufacturing and Engineering to plan and execute validation under the Quality Engineering scope.

Requirements include a Bachelor’s degree in science, Master’s preferred, and 5+ years CQV/validation experience in a GMP/GDP environment with IQ/OQ/PQ protocol

Qualifications

• Bachelor’s degree in science (chemistry, biochemistry, biology or equivalent).
• Master’s degree preferred.
• 5+ years CQV/validation experience in GMP/GDP environment.
• Experience with IQ/OQ/PQ protocols and reports.
• Experience validating utility systems such as purified water and nitrogen.
• Experience planning and executing cleaning validation of lab glassware and equipment.
• Experience with coupon spike and recovery studies for cleaning validation.
• Familiarity with Lean Six Sigma and root cause analysis.
• Understanding of cleaning validation requirements for pharmaceutical industry.
• Knowledge of MAC calculations for APIs and GMP ICH Q7.

Responsibilities

• Develop strategy, acceptance criteria, and generate execution plans for cleaning validation.
• Perform and analyze cleaning recovery studies and validation reports.
• Lead cross‑functional teams to ensure on‑time qualification deliverables.
• Provide validation guidance during project planning and development phases.
• Write validation protocols (DQ/IQ/OQ/PQ) and final reports.
• Plan, write, and execute qualification protocols and reports.
• Conduct investigations related to validation studies and document findings.
• Recommend improvements based on validation outcomes.
• Ensure accuracy and validity of testing results and support inspections.

Skills

CQV experience

Cleaning validation

IQ/OQ/PQ protocols

Utility systems validation

Coupon spike studies

Lean Six Sigma

ICH Q7 GMP knowledge

MAC calculation

CapEx experience

Lab instrumentation

Attention to detail

Education

Bachelor’s degree in science

Master's degree

Job description

Bachem Americas in California is seeking a Quality Engineer (QE) / Validation to support cleaning validation activities for API and PMO manufacturing, plus qualification of equipment, facilities, and utilities. This role partners with Manufacturing and Engineering to plan and execute validation under the Quality Engineering scope.

Requirements include a Bachelor’s degree in science, Master’s preferred, and 5+ years CQV/validation experience in a GMP/GDP environment with IQ/OQ/PQ protocol