Pharma Quality Engineer — CAPA, Deviation & CI
Commissioning Partners LLC.
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Job summary
Commissioning Partners LLC is seeking a Quality Engineer to support quality systems, manufacturing operations, investigations, process improvements, and compliance within a regulated pharmaceutical environment.
The ideal candidate will have experience with deviation investigations, CAPA, change control, risk management, root-cause analysis, and continuous improvement while ensuring compliance with cGMP and company quality standards.
Qualifications
- Bachelor's degree in Engineering, Quality, Life Sciences, or related field.
- 3+ years in quality engineering or regulated manufacturing.
- Experience with deviations, CAPA, change control, RCA, and risk mgmt.
- Strong understanding of cGMP and pharma/biotech processes.
- Experience with root-cause methodologies (5-Why, Fishbone, FMEA).
- Strong technical writing and communication skills.
Responsibilities
- Support quality engineering activities for pharma, biotech operations.
- Investigate deviations, nonconformances, and quality events with RCA.
- Develop and monitor CAPA plans through completion.
- Support change controls and assess impact of changes.
- Review docs, batch records, SOPs, specs for compliance.
- Participate in internal, supplier, customer audits and inspections.
- Assist in SOPs, work instructions, and quality records.
- Monitor quality metrics and drive continuous improvement.
Skills
Education
Tools
Job description
Commissioning Partners LLC is seeking a Quality Engineer to support quality systems, manufacturing operations, investigations, process improvements, and compliance within a regulated pharmaceutical environment.
The ideal candidate will have experience with deviation investigations, CAPA, change control, risk management, root-cause analysis, and continuous improvement while ensuring compliance with cGMP and company quality standards.
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