Our client is a world leading contract development and manufacturing organization of pharmaceutical products. Located in France, the USA, Brazil, and China, we provide comprehensive innovation & development services to fulfil every aspect of contract pharmaceutical manufacturing needs. They specialize in unit dose manufacturing and our expertise includes an extensive range of unit dose packaging, such as Blow-fill-seal (BFS). In addition, we also manufacture preservative-free multidose, pharmaceutical bottles, sprays, tablets, tubes, suppositories and pessaries. l accessories.

The Production Maintenance Manager is responsible for maintenance of all equipment used in the manufacturing and packaging of drug products at the Rochester N.Y. site. The person in this position provides administrative and technical supervision to all Production Maintenance Mechanics.

JOB SUMMARY:

Production Equipment Meets Requirements for Effective Business Operations (50%)

• Develops and manages projects required to provide equipment required to support the business plan.
• Coordinates scheduled and emergency maintenance, repair and improvements to equipment. Manages

ERP work order system and assigns work orders and PM's to staff.

• Identifies future maintenance and/or equipment resources required to meet the business plan.
• Orders parts for preventative maintenance, work orders, routine jobs, and emergency repairs.
• Oversees management of the Preventative Maintenance Program to ensure that all equipment is properly maintained from a functional efficiency standpoint and in compliance with the FDA requirements to have and use a formalized equipment maintenance system.
• Participates in the Quality Improvement Program by performing investigations, writing response reports, and implementing corrective actions for CAPA's that fall within the responsibility of Production Maintenance.

Skills & Performance of People Are Appropriate for Business Needs (25%)

• Ensures self and staff understand the organization's vision, values, goals and strategies and their relationship to their daily work.
• Manages employee performance by clearly defining job responsibilities and standards of performance; tracking progress against goals; providing clear, thorough, timely feedback; and addressing performance problems and issues promptly.
• Helps others to successfully manage organizational change. Facilitates the implementation and acceptance of change within the workplace. Acts as a champion for change. Develops, plans, and follows through on change initiatives. Accepts the ambiguity that comes with change activities.
• Understands HR policies and practices and uses them to manage employees.
• Ensures money, technology, and staff are allocated to achieve optimal results.
• Ensures self and staff keep up-to-date on technical knowledge and developments that impact roles. Uses this information to drive improvements and/or prepare for changing requirements.
• Ensures an effective learning environment by coaching employees, orchestrating learning opportunities, and providing relevant, high-impact feedback.

Production Maintenance Guidance & Advice (25%)

• Provides technical support to all Production Maintenance mechanics in all skill areas including; electrical, mechanical, controls, and operational theory.
• Provides general problem solving expertise, from an equipment perspective, to assist in overcoming operational problems as they occur in the Manufacturing and Packaging areas.

Production Maintenance Manager

• Provides technical support to project teams in the pursuit of new product introductions, line extensions of existing products, or, product and process improvements aimed at improving efficiencies, or quality.
• Attends technical seminars and trade shows and maintains a current knowledge of, equipment related, technical developments in the pharmaceutical industry.

EDUCATION & EXPERIENCE:

• High School Diploma/GED
• 15 years' experience in automated pharmaceutical manufacturing and packaging operations.
• 3 years supervisory experience
• Knowledge of liquid and solid packaging systems.
• Knowledge of Pharmaceutical manufacturing and processing equipment.
• Knowledge of preventative maintenance management systems and maintenance techniques.
• Solid fundamental understanding of mechanical systems and principles.
• Knowledge of FDA, CGMP, NFPA, ADA, OSHA, and New York State and local regulations.
• Budget management including expense budgets and capital project budgets.

KNOWLEDGE SKILLS & ABILITIES:

• Ability to react to maintenance situations and quickly develop and implement solutions to ensure that the Manufacturing and Packaging operations are able to meet the production schedule.
• Develop a proactive rather than reactive environment in Production maintenance.
• Compliance with all regulatory authorities including; FDA, DEA, OSHA, NFPA, EPA, and all state and local codes.
• Ability to manage staff of non-exempt skilled trades.
• ERP systems for purchasing and Preventative Maintenance
• Trackwise quality management system

INDLP

Job Type: Full-time

Pay: $90,000.00 - $105,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 10 years
• 11 years
• 7 years
• 8 years
• 9 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Education:

• High school or equivalent (Preferred)

Experience:

• Pharmaceutical Manufacturing: 8 years (Preferred)
• Maintenance: 8 years (Preferred)
• FDA regulations: 8 years (Preferred)

Ability to Relocate:

• Rochester, NY: Relocate before starting work (Required)

Work Location: In person