Manager, Visual Inspection

Resilience • Blue Ash, OH

1d • $100,000 - $148,750

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 Position Summary This position is a leader for the Process Operation (Visual Inspection). In this capacity, the Visual Inspection Manager manages the Process Operation to produce high quality product in accordance with the operating strategy. As a responsible leader for the operation (potentially with other Supervisors), 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. This manager position will eventually hire and have 4 supervisors within their reporting structure. This position will first serve in the MSAT organization on the asset delivery/tech transfer team to build the VI processes for the new cartridge inspection program. Upon successful tech transfer and commercial handover of the line to operations, this role, along with its direct reports, will transition from MSAT into the Commercial Inspection Operations team.

Requirements

• Experience in GMP or regulated production environment
• Previous supervisory experience
• Experience working in a LEAN manufacturing environment
• Knowledge of FDA cGMP
• Strong communication and leadership skills
• Problem solving skills

Nice To Haves

• Bachelor of Science in engineering, pharmacy, related science, or business
• Previous managerial experience
• Working knowledge of LDMS, Microsoft applications, SAP, Veeva
• Training or experience in visual inspection, packaging, validation, technology transfer, change control
• Knowledge or previous experience in managing technical programs/projects
• Strong mechanical, electrical, troubleshooting, and problem-solving abilities
• Ability to direct and participate in cross-functional teams
• Project Management skills

Responsibilities

• Responsible to build visual inspection processes and procedures for the new cartridge inspection line
• Responsible to build the eventual visual inspection manufacturing team of supervisors and technicians
• Responsible for the operational side of the tech transfer of the new cartridge inspection line
• Provides direction to personnel in the efficient use of equipment and materials to produce quality products in accordance with the Operations Plan or Rhythm Wheel
• Responsible for all Operations 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 EHS standards are met on a daily basis
• Accountable for training of personnel on equipment, processes and Standard Operating Procedures
• 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 and 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 through the use of team driven processes and key performance indicators and recognition and rewarding high performance
• Collaborates with Technical Teams 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

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