cGMP Production Operations Supervisor -- Biomedical Manufacturing
Job Description
Job Description Aegis Worldwide
Role: cGMP Production Operations Supervisor — Biomedical Manufacturing
Details: 3rd shift | $90–$110k | Full-time | Fishers, IN
Day-in-the-life
As the production floor comes alive on third shift, you begin by confirming coverage—reviewing the schedule, PTO, training needs, and any overtime adjustments. You check the production plan, align staffing, and set the shift up for success. On the floor, you’re visible and accessible: coaching operators, clearing roadblocks, and reinforcing a culture of ownership, performance, and continuous improvement.
Quality and safety are constant priorities. You verify adherence to cGMP, FDA, and ISO requirements, audit procedures, and model safe practices with proper PPE. When a deviation or customer concern surfaces, you lead the investigation—driving root cause analysis, documenting manufacturing exceptions, and implementing corrective actions that stick.
Throughout the night, you track KPIs, communicate progress, and adjust in real time. Most of your shift is spent where the work happens—on the production floor—supporting your team and ensuring targets are met with consistency and care.
What you will lead
- Daily production coverage: staffing, scheduling, PTO, training, and overtime aligned to plan
- Team coaching and accountability; building a high-performance, continuous-improvement culture
- Compliance with company policies, quality systems, and global regulatory standards (cGMP, FDA, ISO)
- Investigations, root cause analyses, manufacturing exceptions, and corrective actions for quality, safety, and customer issues
- On-floor leadership: real-time problem solving, KPI communication, and results delivery
Qualifications
- Bachelor’s degree in Manufacturing, Engineering, or related field; equivalent experience may be considered
- 10+ years of relevant manufacturing experience, including regulated cGMP environments
- 2+ years in a supervisory or team lead capacity
- Preferred: Lean, Kaizen, Six Sigma experience; high-performance teams; procedure development
- Ability to work flexible hours in a physically demanding, safety-regulated environment; comfortable with PPE and active participation in safety programs
Aegis Worldwide is partnered with a biomedical manufacturer to hire this full-time leader for the third shift in Fishers, IN.