Description

Job Purpose:

The BFS Maintenance Manager leads and directs all aspects of maintenance operations for Blow-Fill-Seal (BFS) equipment, ensuring maximum equipment availability, regulatory compliance, and team development in a sterile pharmaceutical manufacturing environment. This role combines hands-on technical expertise with strategic planning and personnel management to sustain and improve equipment performance across multiple BFS platforms (e.g., Rommelag 324, 460). The Manager ensures CGMP and safety standards are upheld, oversees long-range maintenance planning, and serves as a critical liaison between Engineering, QA, and Production teams.

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Essential Duties and Responsibilities:

Strategic Maintenance Oversight:

Ø Lead and manage daily, preventive, and predictive maintenance for BFS equipment.

Ø Develop long-term strategies for overhaul planning, equipment upgrades, and system improvements.

Ø Monitor and optimize performance of critical systems including pneumatics, hydraulics, servo motors, vacuum, and compressed air systems.

Ø Ensure readiness and compliance of BFS systems for changeovers, revalidations, and production start-ups.

Team Leadership & Workforce Development:

Ø Provide hands-on leadership and technical support to BFS Maintenance Technicians.

Ø Develop, implement, and maintain a structured technician training program; serve as SME for technical onboarding and continuous development.

Ø Manage staffing levels, scheduling, performance reviews, coaching, and corrective action when necessary.

Ø Create a culture of accountability, teamwork, and safety awareness.

Compliance & Quality Systems:

Ø Ensure all maintenance activities meet FDA, CGMP, and internal SOP requirements.

Ø Own or support investigations (e.g., deviations, CAPAs, change control) involving equipment and utility systems.

Ø Approve and maintain SOPs related to BFS maintenance operations.

Ø Maintain complete and accurate records using CMMS or paper-based documentation.

Cross-Functional Collaboration & Technical Leadership:

Ø Serve as primary maintenance liaison to Production, QA, and Engineering functions.

Ø Provide input during equipment installations, validations, and FAT/SAT activities.

Ø Represent Maintenance during audits, walkthroughs, and cross-department meetings.

Ø Champion continuous improvement initiatives that increase equipment reliability, reduce downtime, and lower maintenance costs.

Utilities & Support Systems:

Ø When necessary, oversee maintenance and functionality of supporting systems (e.g., compressed air, vacuum, leak detection, temperature controls, electrical panels).

Ø Ensure utility integrity during post media maintenance and aseptic area work.

Supplemental Functions:

Ø Performs all other duties as assigned or apparent.

Job Specifications and Qualifications:

Knowledge:

Ø Advanced understanding of BFS systems, cleanroom requirements, and aseptic manufacturing practices

Ø Strong foundation in mechanical and electrical systems, PLCs, power transmission, and instrumentation

Ø Familiarity with Lean Manufacturing, reliability-centered maintenance, and Six Sigma principles

Technical Competencies and Areas of Expertise:

Ø Servo Systems, Electrical & Pneumatics Troubleshooting

Ø BFS Platform Knowledge (Rommelag 324/460 or equivalent)

Ø Preventive & Predictive Maintenance Strategy

Ø Packaging Systems (Bosch NTY, Wilco HVLD, Mettler Toledo, etc.)

Ø Root Cause Analysis / CAPA Implementation

Ø System Validation Support (I/O, logic verification, requalification)

Ø Mechanical, Electrical, and Control System Schematics

Education / Experience:

Ø Associate’s degree or higher in Mechanical, Electrical, or Industrial Engineering preferred

Ø Technical trade certification in maintenance, pneumatics, or electrical systems required

Ø OEM training (Rommelag, Bosch, etc.) preferred.

Ø Minimum 7 years in BFS maintenance, including at least 3 years in a leadership or supervisory capacity

Ø Demonstrated success managing cross-functional teams and supporting validation/commissioning activities

Ø Experience with Weiler, Rommelag, or similar shuttle-type BFS systems

Licensing and Certifications:

Ø OEM certifications in BFS technologies

Ø Lean Six Sigma, OSHA, or other industry-recognized certifications

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Working Conditions / Physical Requirements:

Ø Ability to lift 50–70 lbs and perform physical tasks (crawling, climbing, bending)

Ø Exposure to heat, pressurized systems, and mechanical environments

Ø Standing/walking required for majority of each shift

Ø Must be able to gown for aseptic cleanroom entry and use PPE

Ø Required to work rotating 8-hour shifts , must be available for on-call coverage

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