Supervisor, Manufacturing Device Assembly

Resilience • Blue Ash, OH

2d • $75,000 - $112,500

About The Position

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. For more information, please visit www.resilience.com The Supervisor, Device Assembly is a leader for the Process Operation. In this capacity, the supervisor manages the Process / Package Operation to produce high quality product in accordance with the Process Execution Team (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 requirements, as well as SHE obligations and Resilience standards. Work Schedule: This role will be day shift M-F for several months before it transitions to a 2-2-3 Shift 6am-6:30pm.

Requirements

• Prior experience in a regulated production environment.
• Strong communication and leadership skills.
• Problem solving skills.
• Knowledge or previous experience in managing technical programs/projects
• Strong mechanical, electrical, troubleshooting, and problem-solving abilities.
• Ability to direct and participate in a cross-functional team.

Nice To Haves

• Bachelor of Science in Engineering, Pharmacy, related Science, or business.
• Experience working in a LEAN manufacturing environment.
• Working knowledge of LDMS, Microsoft applications, SAP.
• Training or experience in device assembly, packaging, validation, technology transfer, change control.
• Project management skills.

Responsibilities

• Provides direction to PET staff in the efficient use of equipment and materials to produce quality products in accordance with the PET Plan
• 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 shifts.
• Occasionally performs rolls for PET Lead when designated

Benefits

• Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 501-1,000 employees