Mechanical Engineering Supervisor (Blow Fill Seal)

Company Overview:

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.

Please visit our website at www.keystoneind.com to learn more about Keystone Industries and career opportunities.

Position Details:

• 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: $100,000 - 120,000 annually, based on experience and qualifications.

Essential Functions:

• 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.

Qualifications:

• 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.

Desired Skills:

• 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.

Education/Certifications:

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

Benefits and Perks:

• 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