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.
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We are hiring both Day/ Night hours*
* 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, Pharmacy, related Science or business.
* Experience working in a LEAN manufacturing environment
* Working knowledge of LDMS or Veeva, Microsoft applications, SAP.
* Training or experience in formulation, filling, packaging, validation, technology transfer, change control.
* Knowledge or previous experience with pharmaceutical manufacturing, aseptic filling preferred.
* Strong mechanical, troubleshooting, and problem-solving abilities.
* Ability to direct and participate in cross-functional teams.
* Project management skills
Resilience is an Equal Employment Opport