Senior/Principal Validation Engineer — GMP CQV Leader

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

Benefits offered by this job

Medical/Dental/Vision

401(k) plan

Paid time off

Job summary

Bachem Americas is seeking a Sr / Principal Validation Engineer to support cleaning validation activities for API and PMO manufacturing, and to qualify equipment, facilities, and utilities. You will collaborate with Manufacturing and Engineering to plan and execute validation under the Quality Engineering scope of work, and to monitor validated systems.

The role requires 5+ years in CQV within GMP environments, with hands-on protocol writing, validation reports, and cross-functional leadership.

Qualifications

• Bachelor's degree in science or equivalent.
• 5+ years of 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 performance of validation studies, writing validation protocols and reports and other technical documents, as well as conducting validation related investigations (preferred).
• Experience with developing coupon spike and recovery studies for cleaning validation.
• Experience with Lean Six Sigma methods: root cause analysis, failure mode analysis and analyzing / organizing complex technical problems.
• Understanding of cleaning validation requirements for pharmaceutical industry.
• Knowledge of and ability to perform MAC calculation for APIs.
• Understanding of GMP for Active Pharmaceutical Ingredients per ICH Q7.

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, coach and mentor Quality Engineer I and II.
• Write validation protocols and final reports, test methods, standard operating procedures, and technical reports.
• Planning, writing, and executing qualification protocols (DQ, IQ, OQ, PQ) and reports.
• Independently conduct and document investigations related to validation studies.
• Based on validation studies, evaluate and make recommendations for improvements to operations, processes and methods.
• Accountable for the accuracy and validity of testing results
• Support and assist with inspections and audits.
• Perform other related duties as assigned.
• Plan and perform required periodic re-validation / re-qualification activities
• Work and communicate with different associates within the company to ensure timely completion of assigned tasks and projects.
• Adherence to cGMP and safety procedures and contribute to GMP systems improvements.

Skills

CQV experience

Validation planning

Documentation writing

Lean Six Sigma

GMP knowledge

Critical utilities validation

Troubleshooting investigations

MAC calculation for APIs

QA collaboration

Education

Bachelor's degree in science

Master’s degree in science related field

Job description

Bachem Americas is seeking a Sr / Principal Validation Engineer to support cleaning validation activities for API and PMO manufacturing, and to qualify equipment, facilities, and utilities. You will collaborate with Manufacturing and Engineering to plan and execute validation under the Quality Engineering scope of work, and to monitor validated systems.

The role requires 5+ years in CQV within GMP environments, with hands-on protocol writing, validation reports, and cross-functional leadership.