Mechanical Engineering Supervisor (Blow Fill Seal

Mechanical Engineering Supervisor (Blow Fill Seal)

We are passionate about our employees. We strive to create an environment that is stimulating and motivating and a culture that fosters mutual respect, teamwork, and career development. Come join the Keystone team so we can build your career together!

In addition to competitive starting salaries, we offer a wide variety of competitive benefits, perks and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Title:

Mechanical Engineering Supervisor (Blow Fill Seal)

Schedule:

7:00 am - 3:30 pm, M-F, with flexibility. Longer hours scheduled as needed.

Location:

Gibbstown, NJ (08027)

Salary Range: $100, annually, based on experience and qualifications.

• Manage daily BFS production operations: allocate resources, set priorities, monitor yield, throughput, utilization, and mechanical downtime.
• Lead setup, operation, maintenance and troubleshooting of BFS machinery and associated mechanical systems to produce high-quality sterile products.
• Ensure production processes operate within specification, and that mechanical adjustments and calibrations are done appropriately when required.
• Analyze equipment performance, identify root causes of inefficiencies or failures, and implement corrective and preventative actions (CAPAs).
• Supervise and coach technicians and operators in mechanical/process tasks, ensuring compliance with work instructions, SOPs and batch records.
• Collaborate with Quality Assurance, Manufacturing Engineering, Maintenance, and Supply Chain teams to optimize production flow, mechanical reliability, and process robustness.
• Oversee preventive maintenance and mechanical repairs of BFS equipment.
• Ensure all mechanical and production activities comply with GMP standards, aseptic manufacturing practices, cleanroom protocols, and document control procedures.
• Oversee documentation of mechanical maintenance, calibration, deviations, repairs and batch processing for BFS operations.
• Lead continuous improvement initiatives relating to BFS operations.
• Drive mechanical upgrades, line changes or mechanical process improvements in BFS production in alignment with organizational goals.
• Perform additional duties/tasks as needed or requested by management.

• Minimum of 3–5 years of experience in mechanical engineering or technical maintenance roles in a manufacturing/sterile production environment; preferably with BFS or aseptic filling equipment.
• Proven mechanical aptitude: experience with mechanical systems, rotating equipment, filling machinery, conveyors, pumps, nozzles assemblies, PLC/HMI basics.
• Strong problem-solving skills, root cause analysis capabilities, and mechanical troubleshooting experience in a regulated environment.
• Excellent communication, documentation and interpersonal skills; ability to collaborate and work effectively with cross-functional teams and manage production issues.
• Strong leadership and people management skills, with the ability to lead, motivate, and develop team members in a production setting.
• Ability to work effectively in a fast-paced, team-oriented environment.
• Strong attention to detail and organizational skills.
• Understanding of SOPs, batch records, and cleanroom protocols.
• Must be capable of wearing all protective gear, adhering to all PPE requirements and gowning/garbing procedures.
• Willingness to work flexible hours as needed.

• Familiarity with GMP, ISO standards, aseptic processing, cleanroom classifications, batch record review, deviation investigation and CAPA systems.
• Experience with ERP/MRP systems, CMMS (maintenance tracking), and continuous improvement methodologies (Lean, Six Sigma, 5S).
• Mechanical upgrade or project experience (equipment qualification, mechanical design improvements, performance optimization).
• At least 2 years of supervisory or lead responsibilities (technicians/operators) in a production environment.
• Knowledge of 21 CFR Part 210 and Part 211, FDA, cGMP, OSHA, and EPA standards and requirements.

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering or related technical field or equivalent combination of education and experience.

• Weekly Pay
• Comprehensive Health Coverage
  - Medical, Dental & Vision Plans
• Flexible Spending Accounts (FSA) – Medical & Dependent Care or Health Savings Account (HSA) Options
• Company-Paid Life Insurance + Additional Voluntary Options
• 401(k) Retirement Plan with 3% Employer Contribution (after 1 year)
• Fitness Benefits
  - Onsite Gym (Headquarters) or Membership Reimbursement (other sites)
• Paid Time Off & Holidays to support work-life balance
• Employee Assistance Program (EAP) for confidential support
• Financial Wellness Resources
• Employee Discounts & Perks (Eagles games, concert tickets, etc.)
• Company Social Events & Team Activities
• Career Development Opportunities & Internal Growth

Equal Opportunity Employer This employer is required to notify all applicants of their…