Manufacturing Engineer II
Manufacturing Engineer II - Aseptic Operations
Seeking a Manufacturing Engineer with experience supporting aseptic pharmaceutical or biotech manufacturing operations. This individual will serve as a key technical resource on the production floor, ensuring sterile manufacturing processes remain compliant, efficient, and within established process controls.
Key Responsibilities:
- Provide hands-on technical support during aseptic manufacturing, filling, cleaning, and processing activities.
- Monitor critical process parameters and troubleshoot operational issues in real time.
- Lead investigations related to deviations, CAPAs, root cause analysis, and change controls.
- Author and revise SOPs, batch records, and manufacturing documentation.
- Support process validation, cleaning validation, and continuous improvement initiatives.
- Partner with Quality, Engineering, Validation, and Manufacturing teams to improve process robustness and product quality.
- Train and mentor operators on aseptic techniques and manufacturing best practices.
- Support regulatory inspections, audits, and compliance initiatives.
Qualifications:
- Bachelor's degree in Engineering or a related scientific discipline.
- 3+ years of pharmaceutical or biotech manufacturing, process engineering, or MS&T experience.
- 2+ years of experience supporting aseptic or sterile manufacturing operations.
- Strong knowledge of cGMP regulations, aseptic processing, deviation investigations, CAPA management, and process validation.
- Excellent problem-solving, technical writing, and cross-functional communication skills.
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