Quality/Validation Engineer

Responsibilities

• Develop cleaning validation strategies, establish acceptance criteria, and execute protocols and reports.
• Perform, coordinate, and analyze cleaning recovery studies.
• Plan, write, and execute qualification protocols (DQ, IQ, OQ, PQ) for equipment, facilities, and utilities.
• Lead cross-functional project teams to ensure timely completion of validation deliverables.
• Conduct and document investigations related to validation studies and implement process improvements.
• Monitor validated facility and utility systems, including purified water and nitrogen systems.
• Support inspections and audits while ensuring adherence to cGMP and safety procedures.

Requirements

• Bachelor's degree in a science discipline (Chemistry, Biochemistry, Biology, or equivalent).
• 5+ years of Commissioning, Qualification & Validation (CQV) or cleaning validation experience in a GMP/GDP environment.
• Proven experience with planning, writing, and executing IQ, OQ, and PQ protocols.
• Strong understanding of cleaning validation requirements for the pharmaceutical industry.
• Knowledge of GMP for Active Pharmaceutical Ingredients per ICH Q7.
• Proficiency with Lean Six Sigma methods, including root cause and failure mode analysis.

Preferred Qualifications

• Master's degree in a relevant scientific field.
• Experience with mid-to-large scale CapEx projects.
• Knowledge of MAC calculations for APIs.
• Experience with the validation of critical utility systems such as cold storage units.

Benefits

• Competitive base salary and annual performance bonus.
• Comprehensive Medical, Dental, and Vision coverage.
• 401(k) plan with employer contribution.
• Paid vacation, personal days, and sick days.

About the Company

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of expertise, Bachem provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide.