Manager, Visual Inspection

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.

Position 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

Minimum Qualifications

• 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

Preferred Qualifications

• 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

Work Schedule: During the project portion of this role within MSAT, the work schedule will be dayshift Monday-Friday. When this role transitions into the operations team at commercial handover, this role is expected to flex their schedule to work across shifts at times. The work schedule listed reflects the employee's expected schedule at the time of hire.

The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.