Principal Manufacturing Compliance Engineer
$95,200–$176,800 year
On-siteOceanside, California, United States
Job Summary
Lead root-cause investigations and manage complex technical, regulatory, and compliance issues across biomanufacturing operations in partnership with Quality, MSAT, and Facilities & Engineering. Act as the primary Discrepancy Owner Lead, driving Root Cause Analysis (RCA) sessions and coordinating corrective and preventative action (CAPA) implementations. Perform critical technical reviews and approvals for process validation protocols, engineering changes, variance reports, and controlled documentation while serving as a subject matter expert to regulatory agencies during site inspections. Identify and mitigate risks such as microbial contamination in cleanrooms, track departmental performance metrics, and mentor manufacturing personnel to foster operational excellence and a strong compliance mindset.
Required Qualifications
- Bachelor's degree (BS/BA) in Life Sciences, Engineering, or a related field
- At least 5 years of experience in the pharmaceutical or biopharmaceutical industry
- Direct, hands-on experience with mammalian cell culture and/or purification of biopharmaceutical products
- Thorough working knowledge of cGMPs, FDA, ICH, and European regulatory guidelines
- Proven expertise in Deviation Management Systems (DMS) as a Discrepancy Owner
- Proficiency with CAPA execution and Change Control processes
- Demonstrated ability to lead complex Root Cause Analysis (RCA) investigations
- Ability to write or revise high-quality technical documents, including Standard Operating Procedures (SOPs) and process validation reports
- Strong written and oral communication skills
- Track record of driving cross-functional alignment
- Ability to prioritize assignments independently
- Ability to mentor teams under minimal supervision
- On-site position availability
- Relocation benefits approval
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