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Manufacturing Engineer – Sterile/Vial Filling
Job in
Boca Raton, Palm Beach County, Florida, 33481, USA
Listed on 2026-02-15
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-02-15
Job specializations:
-
Engineering
Validation Engineer, Manufacturing Engineer
Job Description & How to Apply Below
Immediate hiring for Manufacturing Engineer – Sterile / Vial Filling
Key Responsibilities
- Provide hands-on engineering support for aseptic vial filling, stoppering, and capping lines
- Lead equipment setup, changeovers, troubleshooting, and optimization
- Support media fills, PPQ, and commercial production readiness
- Investigate and resolve equipment and process-related deviations
- Support commissioning, qualification, and validation (IQ/OQ/PQ)
- Partner with Validation, QA, and Manufacturing to drive CAPA resolution
- Support preventive maintenance, calibration, and spare parts planning
- Drive continuous improvement to enhance line efficiency and yield
- Ensure compliance with cGMP, SOPs, and FDA regulations
Required Qualifications
- 5–8+ years of experience in sterile injectable manufacturing
- Strong hands-on experience with aseptic vial filling and fill-finish operations
- Experience with media fills and aseptic processing controls
- Experience supporting deviations, investigations, and CAPA
- Strong troubleshooting and root cause analysis skills
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