Supervisor, Manufacturing - Inspection (Nights)

Resilience; Port Union (OH); On-site; USD 75,000 - 113,000; Full time

Job summary

Resilience is a technology-focused biomanufacturing company seeking a Supervisor, Visual Inspection to lead the Process Operation (Inspection) and ensure high-quality product in line with the PET operating strategy. You will manage PET staff, schedule, and drive adherence to cGMP, regulatory, and HSE requirements while maintaining positive employee relations.

Responsibilities include directing PET staff, coordinating support, and promoting safe work practices, documentation, and deviations

Qualifications

• Experience in production environment and leading PET/inspection operations.
• Knowledge of cGMP, regulatory, and HSE standards.
• Experience with training and coaching staff.
• Proven ability to manage deviations, investigations and change control.
• LEAN manufacturing exposure and project management skills.

Responsibilities

• Provides direction to PET staff in efficient use of equipment and materials to produce quality products.
• Coordinates support staff, scheduling and continuous improvement.
• Promotes safe work practices and compliance with HSE standards.
• Trains PET staff on equipment, processes, and SOPs; partners to develop training plans.
• Ensures cGMPs are followed; responds to audits and deviation investigations.
• Authors, reviews, and approves SOPs to improve processes.
• Leads continuous improvement using KPIs and team-driven processes.

Skills

Strong communication

Leadership

Problem solving

Cross-functional teamwork

LEAN manufacturing

Education

Bachelor of Science in Engineering or related field

Tools

LDMS

AZDocs

SAP

Trackwise

Job description

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

The Supervisor, Visual Inspection is a leader for the Process Operation (Inspection). In this capacity, the Supervisor manages the Visual Inspection Operation to produce high quality product in accordance with the PET operating strategy. As a responsible leader for the operation (potentially with other Supervisors/Managers), this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as HSE 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 PET Plan or Rhythm Wheel
• 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 HSE standards are met daily.
• Accountable for training of PET staff on equipment, processes and Standard Operating Procedures. Partners with the 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. Responds to monthly internal audit observations.
• 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 and so on.
• 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.
• 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.
• Occasionally performs rolls for PET Lead when designated

Minimum Requirements

• Previous experience in production environment.
• Strong communication and leadership skills.
• Problem solving skills.
• Ability to direct and participate in cross-functional team.
• Knowledge or previous experience in managing technical programs/projects
• Strong mechanical, electrical, troubleshooting and problem-solving abilities.

Preferred Background

• Bachelor of Science in Engineering, Pharmacy, related Science or business.
• Experience working in a LEAN manufacturing environment
• Working knowledge of LDMS or AZDocs, Microsoft applications, SAP, Trackwise
• Training or experience in formulation, filling, packaging, validation, technology transfer, change control.
• Project management skills.

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.

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. Our target base pay hiring range for this position is $75,000.00 - $112,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge.