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Facilities Operations Lead

2 months ago

Frederick, Maryland, United States Thermo Fisher Scientific Full time
Work Schedule
First Shift (Days)

Environmental Conditions
Ability to lift 40 lbs. independently, Compliance with all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: restrictions on hair products, jewelry, cosmetics, nail polish, fragrances, visible piercings, facial hair, etc., Cold Room/Freezers at -22 degrees, Exposure to loud noises (Equipment/Machinery), Office environment, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowns, gloves, lab coats, ear plugs, etc.), Strong odors (chemical, lubricants, biological products, etc.), Various outdoor weather conditions.

Position Overview:

The Facilities Operations Lead is accountable for orchestrating and establishing preventive (PM) and corrective maintenance assignments for both production and non-production equipment and systems. This role necessitates effective communication with Production Managers, Facilities Managers, Supervisors, and contracted personnel to enhance the maintenance schedule and reduce production interruptions. The Facilities Operations Lead ensures all documentation is maintained in a cGMP and/or ISO audit-ready condition. This pivotal role within the Facilities Department encompasses scheduling, timeline creation, revision and formulation of preventive maintenance task sheets, updating the preventive maintenance calendar, optimizing process flow, revising/creating SOPs and forms, identifying and executing action items, conducting departmental training, and maintaining progress reports.

Key Responsibilities:
  • Schedule preventive (PM) and corrective maintenance tasks for production and non-production equipment and systems. Communicate with Production Managers, Maintenance Managers, Supervisors, and contracted personnel verbally and/or via email to optimize the maintenance schedule and minimize production downtime.
  • Oversee, monitor, and manage service agreements. Collaborate with contractors to renew existing service agreements or formulate new ones. Review service agreements to identify discrepancies, draft requisitions for new or renewal service agreements, and maintain service agreement documentation in an organized manner.
  • Process all work orders. Create copies of original work orders, input them into a tracking database, and store copies in a binder until completion. Review work orders for GDP errors, enter completed work orders into the tracking database, and file them appropriately.
  • Generate Equipment Parts List Reports for inventory management.
Administrative Duties:

Prioritize and assign Preventive Maintenance task sheets and Critical Work Orders to facilities personnel. Ensure all activities conducted during the shift are performed safely and hazard-free. Review all documentation generated during the shift for accuracy, clarity, and compliance with cGMP, including PM Task Sheets, Work Orders, and Logbooks. Assess the equipment PM schedule and propose modifications/improvements to the Sr. Maintenance Mechanic / Facilities Manager. Generate Purchase Order Requisitions and provide status updates to the Facilities Manager. Collaborate with off-site Finance personnel to expedite and facilitate all Finance inquiries. Maintain the site security photo ID and access badge system. Write and review Change Controls, CAPA Reports, and Audit Findings. Report to the Facilities Manager any information regarding ongoing activities, issues, and concerns related to equipment and/or systems and personnel. Coordinate system and equipment shutdowns for repairs and maintenance with Production and Facilities Management. Assist the Facilities Manager in developing training programs. Provide input on employee performance evaluations for those under your supervision to the Sr. Maintenance Mechanic. Supervise in-house projects as assigned by the Facilities Manager. Participate in various teams and attend meetings as assigned. Coordinate maintenance activities during scheduled maintenance outages. Create and maintain department metrics via charts, graphs, and presentations. Perform miscellaneous duties as assigned by the Facilities Manager.

Experience/Requirements:
  • Strong knowledge of site CMMS (Blue Mountain).
  • Proficiency in Microsoft Suite (Excel, including formula creation; Word; Visio; PowerPoint).
  • Good interpersonal skills.
  • Customer-facing skills.
  • General computer proficiency.
  • Ability to work independently, in a team setting, with minimal direction, or under direct supervision.
  • Knowledge of FDA and ISO requirements in a manufacturing/laboratory environment is advantageous.
Education:
  • Minimum of a high school diploma or GED; an associate degree is preferred.
  • Must possess a current and valid driver's license.
Preferred Qualifications:
  • Six years of experience in facilities coordination.
  • Ability to develop reliability reports to assist in identifying areas of concern that could develop into future issues.
  • Soft skills: communication (oral/written), problem-solving, demeanor, necessary pace, influencing skills, leadership skills, and negotiating skills are beneficial.
  • Ability to work independently, in a group setting, with minimal direction, or under direct supervision.
Benefits:

We provide competitive compensation, an annual incentive plan bonus, healthcare, and a variety of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, along with exceptional career and development opportunities. We promote a vibrant company culture that emphasizes integrity, intensity, involvement, and innovation.