3-5 years' experience in mechanical engineering or maintenance in sterile manufacturing, ideally with BFS equipment.
Demonstrated mechanical aptitude with systems like filling machinery and PLC/HMI basics.
Strong problem-solving and troubleshooting expertise in a regulated environment.
Excellent communication and interpersonal skills for cross-functional collaboration.
Solid leadership skills with experience developing and managing teams in production.
Familiarity with SOPs, cleanroom protocols, and attention to detail.
Responsibilities
Manage daily Blow Fill Seal (BFS) production operations, focusing on resource allocation and monitoring performance.
Lead the setup, operation, and maintenance of BFS machinery to ensure high-quality product output.
Ensure compliance with production specifications and carry out necessary mechanical adjustments.
Analyze equipment performance to identify inefficiencies and implement corrective actions.
Supervise and mentor technicians and operators, ensuring adherence to SOPs and work instructions.
Collaborate with various teams to enhance production flow and mechanical reliability.
Oversee documentation of maintenance and calibration activities while driving continuous improvement initiatives.
Benefits
Weekly Pay
Comprehensive Health Coverage - Medical, Dental & Vision Plans
Flexible Spending Accounts (FSA) or Health Savings Account (HSA) options
Company-Paid Life Insurance + Voluntary Options
401(k) Retirement Plan with 3% Employer Contribution after 1 year
Onsite Gym or Membership Reimbursement for Fitness
Paid Time Off & Holidays for work-life balance
Employee Assistance Program for confidential support
Financial Wellness Resources
Employee Discounts on various events
Social Events & Team Activities
Career Development Opportunities.
Full Job Description
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.
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).
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)
