Supervisor, Manufacturing - DAP (Nights)

Resilience; Blue Ash (OH); On-site; USD 75,000 - 113,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

Healthcare benefits

Paid vacation

Job summary

Resilience seeks a Supervisor, Packaging to lead PET operations, ensuring safe, efficient production of high quality biomanufactured products. You will oversee staff, drive improvements, and enforce cGMP and regulatory standards while supporting training and document control.

The role emphasizes cross-functional collaboration, LEAN practices, and adherence to SOPs, with opportunities to contribute to process optimization and life cycle management of PET assets.

Qualifications

• Bachelor-level engineering/science/business degree or-equivalent required.
• Experience leading manufacturing/packaging operations and LEAN manufacturing.
• Knowledge of cGMP, FDA regulations, and change control processes.
• Ability to direct cross-functional teams and manage technical programs/projects.

Responsibilities

• Direct PET staff and manage packaging operations to meet quality and schedule targets.
• Coordinate staff, scheduling and continuous improvement activities.
• Maintain compliance with cGMP, regulatory and SHE standards across operations.
• Develop training plans and ensure staff competency on equipment and procedures.
• Create and review SOPs, document control and deviation investigations as needed.
• Collaborate with OE and PET engineers to optimize process performance.

Skills

Leadership

Communication

Problem solving

Cross-functional teams

Technical program management

Mechanical aptitude

Electrical troubleshooting

Education

BS in Engineering, Pharmacy, related Science, or Business

Tools

LDMS

SAP

Microsoft Office

Job description

Relocation Assistance Offered

A career at Resilience is more than just a job - it is an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that is 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 & Responsibilities

Position Summary & Responsibilities The Supervisor, Packaging is a leader for the Process Operation (Pack). In this capacity, the Supervisor manages the Process / Package Operation to produce high quality product in accordance with the PET operating strategy. As a responsible leader for the operation (potentially with other Supervisor/Managers), this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as SHE obligations and Resilience standards. Note: Pack 7 - Device Assembly, Night Shift

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 SHE standards are met daily.
• Accountable for training of PET staff 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. 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

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

Preferred Background

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

Work Schedule

[12 hour - 2/2/3, Night Shift, 1800 to 0630] The work schedule listed reflects the employees 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. This position may also include the following conditions: [insert options from job description template] 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.

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.

Please Note - Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience.