Responsibilities:
- Implement and supervise production area activities to meet manufacturing goals and project deadlines while ensuring cGMP, EHS, and applicable regulatory compliance.
- Lead daily production operations including scheduling, staffing, material management, compliance, training, and auditing to meet customer requirements (deadlines/quality).
- Interview, hire, coach, motivate, develop, discipline, and conduct annual performance reviews; set objectives and track progress.
- Review/approve/manage batch and system records; support product release and product release timing.
- Emphasize cGMP/EHS-aligned training; develop performance measurement and internal auditing; implement improvements.
- Lead/perform technical reviews, investigations, and process improvement; support integration/validation of new equipment/processes.
- Resolve technical/material/cGMP issues impacting deadlines; troubleshoot deviations.
- Support FDA inspections as needed; perform daily gemba walks to ensure safe practices.
Qualifications:
- HS Diploma/GED + 4+ years related experience OR Bachelorβs in science/engineering/technical field + 2+ years related experience; some leadership preferred.
- Leadership/interpersonal skills; ability to interface cross-functionally.
- FDA-regulated environment experience preferred.
- In-depth process knowledge; ability to manage multiple priorities.
- Analyze/interpret scientific & statistical data; strong documentation and communication; professional writing for technical reports.
- cGMP/regulatory guideline understanding; assessment/troubleshooting skills; ability to present to groups/senior management; may supervise multiple shifts/groups.
- Computer skills (MS Word, MS Excel).
Benefits (explicit): eligible for medical/dental/vision, 401(k) w/ company match, disability and life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, up to 80 hours sick time/year, and up to 120 hours paid vacation for new hires.
Work environment (explicit): controlled/clean room clothing/gowning, cold/wet, chemical exposure with possible respiratory protection, multiple shifts/weekends/OT, standing/walking 8β12 hours, lift/push/pull up to 30 lbs (with equipment), confined area at times.