Job Description
Job DescriptionJob Description
Primary: The position is responsible for ensuring that the D&G QMT US facilities and equipment are maintained at operational readiness in a cGMP and ISO 13485 compliant state. This position oversees a comprehensive preventive maintenance and equipment lifecycle program, coordinates with third-party vendors and contractors and is a key partner to business leadership in the BU’s capital planning and site utilization strategy.
Secondary: This position is responsible for leading, managing, and developing a team of facilities staff to fulfil the department’s mission. The department must be prepared to respond to emergency facility and/or equipment demands 24/7. The D&G QMT’s Environmental Health & Safety (EH&S) Program, which includes responsibility for the Hazardous and Biomedical Waste Management programs, is a key business partner.
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Partner with Site Leads to ensure local resources are deployed effectively to support day-to-day production and on-going qualification of facility equipment.
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Develop and implement best practices to improve efficiency, quality, and cost improvements with an emphasis of in-sourcing calibration and qualification activities.
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Manage Facilities Budget and serve as key stakeholder in D&G QMT’s Capital Budget.
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Maintain a thorough understanding of and adherence to cGMP and safety policies and procedures.
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Write change-orders and create, review and revise Standard Operating Procedures (SOP’s).
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Manage core services, including Utilities, Fire Safety, Property Insurance and Vendor Managed Services such as HVAC, Electrical, Plumbing, coordinating with Property Management as required.
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Utilize the CMMS (e.g. Faciliworks) across available modules, including work order management, asset management, maintenance and calibration activities, etc.
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Oversee the D&G QMT’s Water System, Cold Storage Equipment & Temperature Monitoring program.
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Coordinate, alongside the Supply Chain, Quality and Science & Technology teams, to:
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support in the selection and installation of new assets, including analytical instrumentation and process equipment;
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perform maintenance on pumps, motors, agitators and other equipment;
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problem solve, including non-conformance, deviations and root cause investigations; and
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support continuous improvement programs.
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Ensure that the D&G QMT’s Business Continuity & Disaster Recovery (BCDR) plans are up-to-date and consider the facilities-related components necessary to mitigate disruption to the business.
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Provide on-call support for off-hours emergencies.
Qualifications
Essential Knowledge and Qualifications:
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Highly independent, self-directed and pro-active individual with a positive attitude and goal-oriented focus.
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Strong interpersonal skills, with ability to connect and communicate effectively, both written and verbal, with internal and external customers as well as vendor and service organizations.
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Able to manage multiple priorities, within a fast-paced, innovative environment, while remaining flexible, resourceful and efficient to meet the needs of the organization
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Adept at working within approved budget and developing/implementing cost saving measures that contribute to overall company revenue
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Creative in problem solving and solution development with exceptional attention to detail
Desired Knowledge and Qualifications:
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10 plus years’ experience performing day-to-day facility and equipment related maintenance in cGMP environment within an ISO 13485 Quality System (or similarly regulated environment).
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Bachelor of Science in engineering, facilities management, or a related discipline.
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OSHA-10 / -30 and 40-HR HAZWOPER Certified, preferred.
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Experience managing a team of facilities maintenance technicians.
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Must have direct experience developing & executing qualification protocols and related summary reports.
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Must be able to efficiently perform preventive/predictive maintenance and troubleshoot complex utility systems including PLC’s, electronic systems, HVAC, refrigeration, electrical, air, water, steam, lab equipment, and/or other production equipment.
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Must have experience scheduling and coordinating work with external contractors and services with the goal of minimal impact or disruption to manufacturing or distribution operations.
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Experienced user with CAD, Visio and other design software, preferred.
Additional Information
All your information will be kept confidential according to EEO guidelines.