Company Description

LGC Clinical Diagnostics, part of the LGC Group, has more than 30 years of experience as a leading and trusted global IVD quality manufacturer, with particular expertise in quality measurement tools (QMT) and reagents. Focused on five key areas – clinical biochemistry and immunoassay, serology, molecular diagnostics, clinical genomics, and reagents – it has around 450 employees across its four FDA-registered and ISO 13485-certified facilities in the USA and Ireland, and an ISO 9001-certified facility in England.

LGC Clinical Diagnostics partners with IVD and biopharmaceutical developers, CROs and academic
institutions covering the entire diagnostic pipeline, from concept and early-stage research to accelerated
product development and, ultimately, routine clinical use. It develops and manufactures a
comprehensive portfolio of premium catalogue and custom-developed diagnostic quality solutions and
component materials for the IVD and extended life sciences industry through its four brands, Maine
Standards Company, SeraCare, The Native Antigen Company and Technopath Clinical Diagnostics.
Together, they serve 7,500 customers in over 120 countries, providing products for more than 20
clinical application areas, including infectious diseases, NIPT, diabetes, cardiac disease and oncology.
lgcclinicaldiagnostics.com

Job Description

The Facilities Maintenance and Equipment Technician is tasked with day-to-day facilities activities, including general maintenance tasks, and ensuring that the facility is well organized, safe, and clean. Activities are managed and documented via work orders within Faciliworks – CMMS database. The position conducts routine inspections of premises and equipment, performs preventative maintenance and basic repairs (carpentry, painting, plumbing, etc), and completes work orders in a timely and professional fashion.

Key Responsibilities

• Facility & Equipment Maintenance & Repair
  • Schedule, conduct and maintain records of Preventative Maintenance (PM) and Calibrations on key pieces of equipment located around the facility. Including coordinating with outside vendors, and sourcing replacement parts, identify critical spare parts and maintaining inventory of spare parts.
  • Coordinate with department managers & supervisors on equipment acquisition and installation
  • Ensure equipment availability to support production and logistics activities to efficiently advance products through production to shipment.
• Compliance and ensuring a safe and clean working environment for all employees, vendors and visitors
  • Recognize safety and compliance issues and alert staff and management of any non-conformances
  • Oversee activities performed by contracted vendors
  • Support Safety Committee activities (i.e. fire safety equipment checks, etc.)
  • Maintain tools and workspace in an orderly, clean, and working condition at all times.
  • Understand and implement appropriate waste disposal activities
• Act as a fully proficient user of the CMMS (e.g. Faciliworks) across available modules, including work order management, asset management, maintenance, and calibration activities, etc.
• Support the company’s commitment to continuous improvement by executing best practice solutions.
• Ability to respond to the facility’s emergency demands including on-call availability during warehouse or manufacturing emergencies/outages and weather events.
• Capital project coordination
  • Participate in capital project identification and scoping
  • Coordinate with contractors to ensure successful project implementation.
• Perform other duties as they arise.

Knowledge, Experience and Technical Skills

• Hands on experience validating and executing validation protocols for various equipment
• Experienced with the repair, Calibration, PM, and installation of existing and new equipment/systems
• Previous exposure and working knowledge of automation equipment and exposure to ISO8 Cleanrooms
• Familiarity with CMMS; entering and completing work orders, PM’s, calibrations, etc.
• Ability to read electrical / mechanical schematics, blueprints, repair manuals or parts catalogues as necessary.
• Able to perform general maintenance tasks such as basic carpentry, plumbing, painting, and other duties as required.
• Knowledge of RODI water systems a plus.
• Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, efficient and attention to detail.
• Good interpersonal skills, able to connect and communicate effectively to internal and external customers as well as vendor and service organizations
• Experience coordinating the work of outside vendors.
• Experience with Capital project development and execution.
• Fast learner and adaptable to ongoing changes
• Must be a highly independent, self-directed, pro-active individual with a positive attitude.
• Passion for continuous improvement and demonstrated initiative towards these goals

Qualifications

Education and/or Experience

• Trade school, High school diploma or general education degree (GED) with five years experience in a manufacturing environment
• Or related degree in Biomedical Engineering or technical college with additional 2 years of professional experience

Additional Information

Physical Demands

The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• May occasionally be required to lift and move material weighing up to 50 lbs with appropriate equipment.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Working in both open office settings and biological/chemical manufacturing environments.
• Weekend and off-hour work to accommodate operations schedule, as needed.
• 10% travel to other CDx locations