Position Summary
The Supervisor is a leader for the Process Operation (Formulation & Parts Prep). In this capacity, the Supervisor manages the Process / Package Operation to produce high-quality product in accordance with the PET operating strategy. As a responsible leader for the operation (potentially with another Supervisor), this must be done while maintaining effective employee relations and compliance with cGMP, other regulatory, and SOX requirements, as well as SHE obligations and Resilience standards.
Job Responsibilities
- Provides direction to PET personnel in the efficient use of equipment and materials to produce quality products in accordance with the PET Plan or Rhythm Wheel.
- Responsible for all PET activity, including coordination of support staff, scheduling, and improvement.
- Promotes the use of safe work practices during all aspects of production and ensures all external and Resilience SHE standards are met on a daily basis.
- Accountable for training PET personnel on equipment, processes, and Standard Operating Procedures. Partners with the PET Coach to develop training plans and assists in providing resources for training.
- Ensures cGMPs are used and followed during production so that all FDA and international regulations are met. Responds to monthly internal audit observations.
- Promotes a positive work environment by effectively administering Resilience Human Resources policies and procedures, including Performance Management, communicating information to employees, and responding to their concerns.
- Ensures proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs, etc.
- Generates reports for deviations, assists in investigations, and recommends and implements solutions to resolve deviations. Approves deviation investigations as appropriate. Responds to product defect notifications.
- Authors, reviews, and approves Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies.
- Promotes and encourages continuous improvement in efficiency, quality, production, and safety using team-driven processes, key performance indicators, and recognition and rewarding of high performance.
- Collaborates with OE Engineers and PET Engineers to optimize process performance.
- Participates in the design, selection, installation, and qualification of new equipment, facilities, and processes.
- Reviews, approves, and implements change controls.
- Provides career development and performance management for direct reports.
- Co-owns life cycle management of PET/Facilities assets.
- Works collaboratively within and across PETs to ensure flow of product, sharing of best practices, and lean behavior.
- Maintains presence across multiple shifts.
- Occasionally performs the role of PET Lead when designated.
- Works effectively in a team environment.
- Able to work in a changing and demanding environment.
Minimum Requirements
- Prior experience in a GMP or regulated production environment
- Previous supervisory experience
- Knowledge of FDA cGMPs
- Strong communication and leadership skills
- Problem-solving skills
Preferred Background
- Bachelor of Science in Engineering, Pharmacy, related Science, or Business
- Experience working in a LEAN manufacturing environment
- Working knowledge of LDMS or Veeva, Microsoft applications, and SAP
- Training or experience in formulation, filling, packaging, validation, technology transfer, or change control
- Knowledge of or previous experience managing technical programs or projects
- Strong mechanical, electrical, troubleshooting, and problem-solving abilities
- Ability to direct and participate in cross-functional teams
- Project management skills
Key Relationships
- Internal: PET and other PETs (including other PET Managers), Technical Manager, OEM Suppliers, Quality Assurance, Filling
- External: Other Supply & Demand Sites
Sponsorship or support for work authorization, including visas, is not available for this position.
