Senior Validation Engineer - GMP/CQV Specialist

Bachem Holding AG; Vista (CA); On-site; USD 121,000 - 166,000; Full time

Benefits offered by this job

Performance bonus

Medical/Dental/Vision coverage

401(k) employer contribution

Paid vacation

Job summary

Bachem Americas is seeking a Sr./Principal Validation Engineer to lead cleaning validation activities for API and PMO manufacturing, and to qualify equipment, facilities, utilities in a GMP environment. You will collaborate with Manufacturing, Engineering, and Quality groups to plan and execute validation studies.

You will write protocols and reports (DQ/IQ/OQ/PQ), perform recovery studies, manage cross-functional teams, and mentor junior engineers.

Qualifications

• Bachelor's degree in science discipline (chemistry, biochemistry, organic chemistry, biology, microbiology, chemical engineering or equivalent).
• Master’s degree in science related field (engineering, chemistry, biology or equivalent). (preferred)
• 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 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
• 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

IQ/OQ/PQ protocols

GMP/GDP environment

Cleaning validation

Lean Six Sigma

GMP for ICH Q7

MAC calculation

Lab instrumentation

Planning & documentation

Critical utility systems

Education

Bachelor's degree in science

Master’s degree (preferred)

Job description

Bachem Americas is seeking a Sr./Principal Validation Engineer to lead cleaning validation activities for API and PMO manufacturing, and to qualify equipment, facilities, utilities in a GMP environment. You will collaborate with Manufacturing, Engineering, and Quality groups to plan and execute validation studies.

You will write protocols and reports (DQ/IQ/OQ/PQ), perform recovery studies, manage cross-functional teams, and mentor junior engineers.