Job Information
RESILIENCE US INC Supervisor, Manufacturing in Hamilton, Ohio
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 Position will start out working M-F for the initial 12+ months supporting project work and then will transition to 12 hour shift (6am/pm-6pm/am-2 days on, 2 days off, every other weekend) * Provides direction to PET (Process Execution Team) personnel in the efficient use of equipment and materials to produce quality products in accordance with regulations and client's requirements. * 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 on a daily basis. * Accountable for training of PET personnel on equipment, processes and Standard Operating Procedures. Partners with PET Coach to develop training plans and assist in providing resources for training. * Performs aseptic behavior compliance Gemba walks to coach and ensure compliance with aseptic filling. * Ensures that cGMP's and SOPs are used and followed during production of products. * Promotes a positive work environment by effectively administering Resilience Human Resources 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, etc. * 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. * Provide career development and performance management for direct reports. * Work collaboratively within and across PETs to ensure flow of product, sharing of best practices and lean behavior. * Maintain presence across multiple shifts. * Occasionally performs rolls for PET Lead when designated. * Ability to work effectively in a team environment. * Candidate should possess the ability to work in a changing/demanding environment. Minimum Requirements * Prior experience in GMP or regulated production environment * Previous supervisory experience. * Knowledge of FDA cGMP's. * Strong communication and leadership skills. * Problem solving skills. Preferred Background * Bachelor of Science in Engineering or related Science or business. * Experience working in a LEAN manufacturing environment * Working knowledge of LDMS or Veeva, Microsoft applications, SAP. * Training or experience in Automated and manual visual inspection or packaging * Knowledge or previous experience with pharmaceutical manufacturing * Strong mechanical, troubleshooting, and problem-solving abilities. * Ability to direct and participate in