Jobs · Manufacturing · Indiana

Manufacturing Supervisor, Finishing (2nd Shift)

Simtra BioPharma Solutions · Bloomington, IN · 1 mo ago
On-siteManufacturingFull-time

The role

The Supervisor is a key member of the Finishing Leadership Team and reports directly to the Finishing Operations Manager. This role is responsible for supporting day-to-day operations in the Finishing production area, ensuring safe and efficient execution of the production schedule in compliance with current Good Manufacturing Practices (cGMP) and safety standards. The Supervisor leads a team of direct reports and cross-functional partners to drive performance, optimize equipment efficiency, and identify opportunities for continuous improvement using LEAN Manufacturing principles. This role requires a hands-on leader who can effectively support and enhance production floor activities, while fostering a culture of operational excellence.

Strong communication skills are essential, as the Supervisor regularly interacts with production team members, management at various levels, and support departments. The ideal candidate will demonstrate a commitment to safety, quality, and productivity, and will uphold the highest standards of SISPQ (Safety, Identity, Strength, Purity, and Quality) in all aspects of production.

Responsibilities

  • Understand and follow current Good Manufacturing Practices
  • Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations
  • Interview, hire, mentor, and develop staff. Conduct annual performance reviews for all direct reports. Assists in setting performance objectives and development plans
  • Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities – to meet customer requirements including deadlines and quality standards
  • High percentage of Gemba (shop floor) presence
  • Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution
  • Aid in meeting product release time goals
  • Implement and support training programs designed to enable staff to consistently carry out all manufacturing processes with strict compliance to cGMPs and EHS regulations
  • Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments
  • Lead technical reviews, investigations and process improvement projects
  • Provide manufacturing input into integration and validation of new equipment and processes
  • Resolve technical, material and cGMP problems that may impact project deadlines
  • Provide guidance and troubleshooting assistance as needed during a deviation in the process; applying Root Cause Analysis (RCA) tools when applicable
  • Represent the company during audits and inspections
  • Author Non-conformance investigation reports (NCRs)

Desirable qualifications

  • High School diploma or GED required
  • Minimum 2 years of manufacturing experience required
  • Minimum 1 year leadership experience required
  • In-depth process knowledge of related manufacturing equipment and processes preferred
  • Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, Trackwise, SCADA (or similar) system, etc.)

Physical / safety requirements

  • Required to stand for over 4 hours per day, including constant standing for 2 hours at a time
  • Duties may require overtime work, including nights and weekends
  • Use of hands and fingers to manipulate equipment is required

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