Job 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. 

 

Partner with Site Leads to ensure local resources are deployed effectively to support day-to-day production and on-going qualification of facility equipment.   
Develop and implement best practices to improve efficiency, quality, and cost improvements with an emphasis of in-sourcing calibration and qualification activities. 
Manage Facilities Budget and serve as key stakeholder in D&G QMT’s Capital Budget. 
Maintain a thorough understanding of and adherence to cGMP and safety policies and procedures. 
Write change-orders and create, review and revise Standard Operating Procedures (SOP’s). 
Manage core services, 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. 
Oversee the D&G QMT’s Water System, Cold Storage Equipment & Temperature Monitoring program. 
Coordinate, alongside the Supply Chain, Quality and Science & Technology teams, to: 
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; and 
support continuous improvement programs.  
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. 
Provide on-call support for off-hours emergencies.

Qualifications

Essential Knowledge and Qualifications:

Highly independent, self-directed and pro-active individual with a positive attitude and goal-oriented focus. 
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.  
Able to manage multiple priorities, within a fast-paced, innovative environment, while remaining flexible, resourceful and efficient to 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 Science in 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.

SeraCare Clinical Diagnostics

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