Senior Validation Engineer: GMP CQV Lead

Bachem Americas, Inc.; Vista (CA); On-site; USD 104,000 - 166,000; Full time

Benefits offered by this job

Competitive pay

Performance bonus

Medical/Dental/Vision coverage

401(k) with employer contribution

Job summary

Bachem Americas, Inc. is seeking a Sr./Principal Validation Engineer to drive cleaning validation and CQV activities across API and PMO manufacturing.

You will plan, execute, and document qualification studies, mentor staff, and interact with Manufacturing and Engineering to ensure compliant, timely deliverables. The role requires strong GMP knowledge, experience with IQ/OQ/PQ, and the ability to lead cross-functional teams, write reports, and support audits.

Qualifications

• 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 cleaning validation of production lab glassware and equipment including the preparation and investigation of validation studies.

Responsibilities

• Develop strategy, establish acceptance criteria, generate, execute cleaning validation protocols and reports.
• Perform, coordinate, execute and analyze cleaning recovery studies.
• Lead cross-functional project teams to address issues and ensure on-time completion of all qualification/validation deliverables.
• Provide qualification/validation guidance and strategy during project planning and development phases; train and mentor junior staff.
• Write validation protocols and final reports, test methods, SOPs, and technical reports.
• Plan and execute qualification protocols (DQ, IQ, OQ, PQ) and reports.
• Independently conduct investigations related to validation studies and document results.
• Evaluate data to recommend improvements to operations, processes and methods.
• Ensure accuracy and validity of testing results; support inspections and audits.

Skills

CQV experience

IQ/OQ/PQ

Validation planning

GMP knowledge

Lead cross-functional teams

Regulatory investigations

Technical writing

Troubleshooting

Education

Bachelor's degree in science or engineering

Master's degree (preferred)

Tools

LIMS/Quality systems

Job description

Bachem Americas, Inc. is seeking a Sr./Principal Validation Engineer to drive cleaning validation and CQV activities across API and PMO manufacturing.

You will plan, execute, and document qualification studies, mentor staff, and interact with Manufacturing and Engineering to ensure compliant, timely deliverables. The role requires strong GMP knowledge, experience with IQ/OQ/PQ, and the ability to lead cross-functional teams, write reports, and support audits.