Senior Lead Validation Engineer, CQV & GMP

Bachem Holding AG; Northern (KY); Hybrid; USD 121,000 - 166,000; Full time

Benefits offered by this job

Competitive pay

Annual performance bonus

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation, personal and sick days

Job summary

Bachem Americas is seeking an experienced Principal Engineer to lead CQV activities in a GMP/GDP environment. The role requires planning and executing IQ, OQ, and PQ protocols, validating critical utility systems, and guiding cross‑functional teams to ensure on‑time completion of qualification deliverables.

The candidate will mentor junior staff, develop validation strategies, and support inspections and GMP improvements across the organization.

Qualifications

• 5+ years of Commissioning, Qualification and Validation (CQV) experience in a GMP/GDP environment.
• Experience planning, writing and executing IQ/OQ/PQ qualification protocols and reports.
• Experience validating critical pharmaceutical utility systems (purified water, nitrogen, cold storage).
• Experience cleaning validation of production lab glassware and equipment; writing protocols and reports.
• Experience developing coupon spike and recovery studies for cleaning validation.
• Knowledge of Lean Six Sigma methods and problem solving.
• Understanding of GMP for Active Pharmaceutical Ingredients per ICH Q7.

Responsibilities

• Develop strategy and acceptance criteria for cleaning validation.
• Write and execute cleaning validation protocols and reports (DQ/IQ/OQ/PQ).
• Lead cross‑functional project teams to ensure on‑time deliverables.
• Provide qualification/validation guidance during project planning and development.
• Mentor Quality Engineer I and II.
• Plan and perform qualification studies and investigations; document results.
• Evaluate validation data and propose operational improvements.
• Support inspections and audits and ensure GMP compliance.

Skills

CQV experience

GMP compliance

LEAN Six Sigma

Root cause analysis

Validation planning

Education

Bachelor's degree in science

Master’s degree in science (preferred)

Job description

Bachem Americas is seeking an experienced Principal Engineer to lead CQV activities in a GMP/GDP environment. The role requires planning and executing IQ, OQ, and PQ protocols, validating critical utility systems, and guiding cross‑functional teams to ensure on‑time completion of qualification deliverables.

The candidate will mentor junior staff, develop validation strategies, and support inspections and GMP improvements across the organization.