Manager, Process Equipment Maintenance & Engineering at Ferring Pharmaceuticals Inc. in parsippany, New Jersey

Posted in Other 25 days ago.





Job Description:

Job Title:

Manager, Process Equipment Maintenance & Engineering

Job Description:

Contribute to outstanding innovation + Make braver choices

Manager, Process Equipment Maintenance & Engineering

Location: Parsippany

As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our 'people first' philosophy. Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.

Summary:

This position is responsible for planning, organizing and controlling Process Equipment Maintenance & Calibration activities on a daily basis with responsibility for results in terms of costs, methods, and employee management & engagement. The incumbent develops and administers schedules and performance requirements for Process Equipment Maintenance staff to drive continuous improvement and sustainable organizational growth and acts as a coach and mentor to direct reports to help meet schedules and resolve technical challenges.

Responsible to collaborate and interact with internal and external stakeholders, Regulatory Compliance, QA, Operations, Planning and Regulatory Agencies (i.e. FDA & EMA). Coordinates and plan maintenance activities accordingly to enhance asset performance. Provide technical support to the entire engineering group and cross-functional teams, as needed.

Responsible for the management of equipment performance and overall lifecycle using the EAMs System (i.e. Equipment onboarding, work order management, periodic reporting and retirement), as well as leading EAMs training ensuring staff are adequately trained to efficiently utilize the system. Responsible to provide alarm response strategy for the BMS/EMS Process Equipment alarms and promptly initiate mitigation plans.

The Maintenance manager will be responsible for the whole of the EAMS inputs and outputs for all Process Equipment maintenance needs. Manage overall compliance requirement for the group, including change management, deviation management and Occupational, Health and Safety regulations. Set and implement short and long-range goals for the group; set priorities, assign responsibilities, and drive high performance.

Perform future need forecast through asset life expectancy management and closely monitor building infrastructure to ensure long term sustainability and successful growth of the organization.

Manage the coordination of the calibration and maintenance program for: GxP equipment, systems for Production, Packaging and Laboratories. This role is for the Ferring commercial manufacturing site located in Parsippany NJ. Incumbent will manage the Process and Packaging Equipment Maintenance staff including Process Engineers and Calibration Technicians.

The incumbent will also support the Manufacturing technical team for new products start up, major GxP equipment upgrade or repair, complex trouble shooting and solving deviation report in a timely manner.

In this role the Maintenance manager will be responsible to forecast his resources; Budget, People, Parts, Vendors, etc

Responsibilities:


  • Process Equipment and Instrumentation operation, life cycle planning and capacity forecasting.

  • Integrated reporting of maintenance activities to the Director of F&M.

Maintenance:


  • Responsible for managing process equipment maintenance and calibration through the use of the EAMS system.

  • Ensure EAMS is utilized to make the Facility and Maintenance department more efficient.

  • Ensure factual and pertinent monthly reporting.

  • Site engineering lead to assure calibration and maintenance program align with Ferring's corporate standards maintaining the GMP equipment and utilities within a validated state of control.

Qualification:

  • Aids in the planning of CQV activities, schedules, system boundaries/breakdowns and in interfacing with Project Planning, Technical Operations and Engineering.

Quality:


  • Initiate, track and resolve non-conformances associated with OOTs encountered during routine PM and calibration activities.

  • Change & Deviations management. CAPAs, etc.

  • Responsible for the overall performance and quality of Process equipment and instrumentation, including compounding system, Parts Washer, Parts Autoclave, Vial Washer and Tunnel, Filler, Lyophilizer and capping equipment. commercial manufacturing site located in Parsippany NJ.

Operations:


  • Author SOPs as needed to support calibration and maintenance programs.

  • Prepare daily work schedules for direct reports.

  • Assist site management in all startup activities associated with new and/or modified areas within the production department up to but not limited to commissioning activities.

  • Support complex product transfer projects, installation of new process equipment and other capital projects as required.

For the systems he is responsible for:


  • Ensure good functionality of the Process Equipment and instrumentation systems (24h / 365 days).

  • Identify and manage maintenance risks develop mitigation plans.

  • Prepare preventive maintenance schedule, budget, resource needs and economical evaluation.

  • Define technical standards for projects and prepare budget (CAPEX & OPEX).

  • Responsible for monthly reporting on KPI's for deviations, CAPA and change control.

  • Responsible to propose improvement/correction from trending on deviation, CAPA, change control, break down.

  • -Oversees, reviews, or manages outside services, contractors and/or maintenance workers engaged in equipment installation and upgrades.

Requirements:


  • Bachelor's degree in Engineering or related field, or equivalent combination of education and work-related experience, required.

  • Minimum 10 years in Maintenance role and or facility start up or in GMP equipment installation, start-up and maintenance or supervisory experience in metrology and/or instrumentation & controls

  • Minimum 5 years' experience in maintaining and utilizing maintenance systems. (Maximo, EAMS, etc).

  • Good leadership skills to manage people and coordinate their work.

  • Demonstrates potential for technical proficiency, engineering creativity, collaboration with others, and independent thought.

  • Demonstrated troubleshooting and problem solving skills including the use of designed experiments. Strong teamwork skills.

  • Ability to plan and manage multiple tasks/projects Good influencing and negotiation skills to accomplish the same goals for internal and external stakeholders according to Project and business need. Understanding engineering disciplines, work package management and work package control. Knowledge of project planning tools and Microsoft office applications.

Join our team and you'll become part of a close-knit family - one in which you'll be listened to and your contributions valued.

Surrounded by like-minded people, you'll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team.

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected
Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Location:

Parsippany