Primary: Theposition is responsible forensuring thattheD&G QMT USfacilities andequipmentaremaintained atoperational readinessin a cGMPand ISO 13485compliant state.This position oversees acomprehensivepreventive maintenance and equipment lifecycle program, coordinates with third-party vendors and contractorsandis a key partner to business leadership in the BU’s capital planning and site utilization strategy.
Secondary:This positionis responsible for leading, managing, and developing a team of facilities staff to fulfil the department’smission. The department must be prepared to respond to emergency facility and/or equipment demands 24/7. TheD&G QMT’sEnvironmental Health & Safety (EH&S) Program,whichincludes responsibility forthe Hazardous and Biomedical Waste Management programs, isa key business partner.
- Partner with Site Leads to ensure local resources are deployed effectively to support day-to-day productionand on-going qualification of facility equipment.
- Develop and implement best practices to improve efficiency, quality, and cost improvementswith an emphasis of in-sourcingcalibration and qualification activities.
- Manage Facilities Budget and serve as key stakeholder inD&G QMT’sCapital Budget.
- Maintain a thorough understanding of and adherence to cGMP and safety policies and procedures.
- Write change-ordersandcreate, review and revise Standard Operating Procedures (SOP’s).
- Manage coreservices, including Utilities, Fire Safety, Property Insurance and Vendor Managed Services such as HVAC, Electrical, Plumbing, coordinating with Property Management as required.
- Utilize the CMMS (e.g.Faciliworks)across available modules, including work order management, asset management,maintenance and calibration activities, etc.
- OverseetheD&GQMT’sWater System,Cold StorageEquipment&Temperature Monitoring program.
- Ensure that theD&G QMT’sBusiness Continuity & Disaster Recovery (BCDR) plans are up-to-date and consider the facilities-related components necessary to mitigate disruption to the business.
- Provide on-call support for off-hours emergencies.
- Support in the selection and installation of new assets, including analytical instrumentation and process equipment.
- Perform maintenance on pumps, motors, agitators and other equipment.
- Problem solve, including non-conformance, deviations and root cause investigations.
- Support continuous improvement programs.
Essential Knowledge and Qualifications
- Highly independent, self-directedandpro-active individual with a positive attitudeand goal-oriented focus.
- Strong interpersonal skills,withabilityto connect and communicate effectively, both written and verbal, withinernal and external customers as well as vendor and service organizations.
- Able to manage multiple priorities, within a fast-paced, innovative environment, while remaining flexible, resourceful and efficientto meet the needs of the organization
- Adept at working within approved budget and developing/implementing cost saving measures that contribute to overall company revenue
- Creative in problem solving and solution development with exceptional attention to detail
Desired Knowledge and Qualifications
- 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).
- Bachelor of Sciencein engineering, facilities management, or a related discipline.
- OSHA-10 / -30 and 40-HR HAZWOPER Certified, preferred.
- Experience managing a team of facilities maintenance technicians.
- Must have direct experience developing& executing qualification protocols and related summary reports.
- 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.
- 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.
- Experienced user with CAD, Visio and other design software, preferred.
All your information will be kept confidential according to EEO guidelines.
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