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Manager, Manufacturing

2 months ago

Hamilton, United States RESILIENCE US INC Full time

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) Brief Job Description Manager, Packaging is a leader for the Process Operation (Packaging). In this capacity, the Manager manages the Process / Packaging Operation to produce high quality product in accordance with the PET (Process Execution Team) operating strategy. As a responsible leader for the operation, this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as EHS obligations and Resilience standards. Job Responsibilities * Provides direction to PET staff in the efficient use of equipment and materials to produce quality products in accordance with the area Standard Operating Procedures. * Responsible for all PET activity to include coordination of support staff, scheduling and continuous improvement. * Promotes the use of safe work practices during all aspects of production and ensures all external and Resilience EHS standards are met on a daily basis. * Accountable for training of PET personnel 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. Serves as a SME of their process during internal and external audits and responds to observations in their area of ownership. * 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, etc. * Generates reports for deviations, assists in the investigations, and recommends/implements solutions to resolve deviations. Initiates, owns, and approves deviation investigations as appropriate. * Responds to product complaint 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 through the use of team driven processes and key performance indicators and recognition and rewarding high performance. * Collaborates with MSAT, OpEx Engineers & PET Engineers to optimize process performance. * Participates in the design, selection, installation and qualification of new equipment, facilities, and processes as needed. * Owns, assesses, 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 in their area of ownership and communicates across multiple operating shifts. * Occasionally performs roles for Senior Manager when designated. * Collaborates with other shift teams and operations to improve the process. Minimum Requirements * Extensive experience in GMP or regulated en