Quality Engineer – Validation

Bachem

Quality Engineer (QE) fulfilling critical role in GMP operations for cleaning validation activities. Collaborating with Manufacturing and Engineering to execute validation activities in the pharmaceutical industry.

Posted 5/27/2026full-timeSan Diego • California • 🇺🇸 United StatesMid-LevelSenior💰 $84,274 - $115,877 per yearWebsite

About the role

Key responsibilities & impact

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
Train, coach and mentor team members
Plan and perform required periodic re-validation / re-qualification activities

Requirements

What you’ll need

Bachelor’s degree in science discipline (chemistry, biochemistry, biology or equivalent)
5+ years of Commissioning, Qualification & Validation (CQV) / cleaning validation 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
Understanding of cleaning validation requirements for pharmaceutical industry

Benefits

Comp & perks

Medical/Dental/Vision coverage
401(k) plan with employer contribution
Paid vacation
Personal and sick days
Annual performance bonus

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

cleaning validationqualification protocolsIQOQPQcleaning recovery studiesre-validationre-qualificationpharmaceutical utility systemsGMP

Soft Skills

leadershipcoachingmentoringproject managementcommunication

Certifications

Bachelor’s degree in science