Manager, Facility Compliance Jobs

The Manager, Facility Compliance will report to the Director Facilities and Engineering. The role of manager is to provide leadership towards improving work force productivity and quality by anticipating and eliminating potential delays. Develop staff so they will be able to plan, schedule, and coordinate equipment maintenance. Accountable for the oversight of planning and coordination of all planned maintenance activities performed at the site occur. Provide regulatory guidance and GMP training to facilities and engineering team to maintain a high level of quality.

Catalent Cell & Gene Therapy hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

The role:

• Management of the planning, maintenance and compliance function for Facilities and Engineering
• Generate SOP’s, deviations, and change control as required for related Facilities systems.
• Participate in client and regulatory audits, audit responses and follow up corrective actions when required.
• Keep the leadership of Facilities and Engineering informed of abnormal or critical situations and seek advice on matters outside the Planner's knowledge or authority.
• Administrator of Blue Mountain calibration and maintenance software program.
• Coordinates all Calibration activities with metrology team and manufacturing.
• Ensure that all facility utilities preventive maintenance is performed in accordance with cGMP guidelines.
• Lead compliance effort in facilities and engineering ensuring group operates in accordance to Catalent's cGMP quality system.
• Ensure all work orders are completed and be able to prepare reports when asked. Consults with requester, maintenance supervisor, engineers or craftsman when necessary.
• Communicate with senior leadership and Catalent personnel to bring them up to date on major repairs, planned and unplanned events that may disrupt manufacturing schedule.
• Reviews, plans and schedules all recurring PM (preventive maintenance) activities
• Manage plans for calibration and preventative maintenance of all GMP equipment, lab equipment, and utilities. Utilities to include clean steam, WFI, RO/DI water, boilers, compressed gases, HVAC systems, electrical, life safety, and emergency power system (UPS).
• Ensure plans and schedules for shutdowns are timely. (major and minor).
• Revise SOP’s as required for updated systems and procedures
• Ensure all PM and repair activities are coordinated with manufacturing operations, purchasing, materials management, maintenance personnel and maintenance management
• Ensure CMMS system is current and assist personnel in locating historical files.
• Maintain departmental industry compliance in support of GMP Manufacturing, Product Development administrative and laboratory activities.

The candidate:

• High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
• Experience leading cross functional teams in a fast-paced environment.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• BS degree in a technical field or equivalent experience.
• Willingness to put internal customer needs first.
• Hands on experience with CMMS software including Blue Mountain Regulatory Asset Manager.
• Good working knowledge of facilities equipment and O&M requirements
• Experience with Building Management software strongly preferred.
• Understanding of GMP compliance for facilities.
• 7 plus years in a supervisor/leadership role
• 5 plus years of GXP quality system experience.
• Strong understanding of proper OSHA safety practices and procedures
• Great attention to detail leaving no loose ends in workload.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

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