Manufacturing Quality Engineer Lead
$91,000–$100,000 year
On-siteShirley, New York, United States
Job Summary
Manufacturing Quality Engineer Lead responsible for ensuring timely investigations and CAPAs related to aseptic manufacturing. Partners with Manufacturing and the Process Investigations Team to bring visibility to open investigations and ensure compliance with regulatory requirements. Applies a scientific, risk-based approach to maintain product quality and patient safety; leads training, qualification, and compliance activities for personnel involved in aseptic manufacturing; writes technical documents (SOPs, CAPAs, protocols, batch records, risk assessments); drives CAPAs to timely completion; collaborates across functions to improve aseptic training, environmental monitoring and compliance; participates in audits and supports continuous improvement initiatives; capable of leveraging root-cause analysis tools (e.g., 5 Whys, Fishbone diagrams) and data presentation in operational settings.
Required Qualifications
- Bachelor’s degree in microbiology, Biology, Engineering, or relevant scientific discipline, preferred
- Equivalent years of experience to be considered
- Minimum 2-5 years of experience in pharmaceutical microbiology, sterile manufacturing, environmental monitoring, and/or quality engineering
- Expertise in aseptic techniques, gowning procedures, and environmental monitoring requirements
- Experience with regulatory requirements (cGMP, FDA, etc.) and quality systems (CAPA, deviation management)
- Excellent communication skills, both verbal and written, with the ability to interact effectively at all organizational levels
- Proficiency in MS Office Suite and project management tools
- Flexibility to work across shifts and adapt to changing priorities in a dynamic manufacturing environment
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