Supervisor, Manufacturing - DAP (Nights)

About the role

A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

Responsibilities

The Supervisor, Packaging is a leader for the Process Operation (Pack). 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 other Supervisor/Managers), this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as SHE obligations and Resilience standards. Note: Pack 7 - Device Assembly, Night Shift.

• Provides direction to PET staff 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 to include 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 daily.
• Accountable for training of PET staff on equipment, processes and Standard Operating Procedures.
• Partners with Process Lead and Training Coordinator to develop training plans and assist in providing resources for training.
• Ensures that cGMP’s are used and followed during production of products so that all FDA and international regulations are met.
• Responds to monthly internal audit observations.
• Promotes a positive work environment by effectively administering people policies and procedures including Performance Management and by 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 and so on.
• Generates reports for deviations, assists in the investigations, and recommends/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 and key performance indicators and recognition and rewarding high performance.
• Collaborates with OE Engineers & 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 control.
• Provides career development and performance management for direct reports.
• Co-owns life cycle management of PET/facility assets
• Works collaboratively within and across PETs to ensure flow of product, sharing of best practices, and lean behaviors.
• Maintains presence across multiple operating