Mechanical Engineering Supervisor (Blow Fill Seal)

About the Company

We are passionate about our employees and strive to create an environment that is stimulating and motivating, fostering mutual respect, teamwork, and career development. In addition to competitive starting salaries, we offer a wide variety of benefits, perks, and programs to support both professional and personal goals.

About the Role

Manage and supervise daily Blow Fill Seal (BFS) production operations, ensuring high-quality sterile product manufacturing. This role involves leading mechanical engineering tasks, troubleshooting, maintenance, and continuous improvement initiatives in a regulated, fast-paced environment.

Responsibilities

• 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 performed appropriately.
• 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 process improvements in BFS production in alignment with organizational goals.
• Perform additional duties/tasks as needed or requested by management.

Requirements

• 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, nozzle assemblies, and 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 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 following gowning/garbing procedures.
• Willingness to work flexible hours as needed.

Qualifications

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

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.

Schedule

7:00 am – 3:30 pm, Monday through Friday, with flexibility for longer hours as needed.

Pay

$100,000 – $120,000 annually, based on experience and qualifications.

Benefits

• Weekly pay.
• Comprehensive health coverage: medical, dental, and vision plans.
• Flexible Spending Accounts (FSA) – medical and dependent care – or Health Savings Account (HSA) options.
• Company-paid life insurance plus 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 and holidays to support work-life balance.
• Employee Assistance Program (EAP) for confidential support.
• Financial wellness resources.
• Employee discounts and perks (e.g., Eagles games, concert tickets).
• Company social events and team activities.
• Career development opportunities and internal growth.