Lead Facilities Maintenance Technician

Key Objectives of the role:

•Develop and maintain a complete working knowledge of all infrastructure systems and operations at the facility.

•Respond to all site infrastructure, utility, and IT mission-critical equipment alarms and execute repair and mitigation activities.

•Ensure that the critical environment is restored to its original maintenance condition following repairs or interventions.

•Support site customer infrastructure facility needs to ensure continuous operations.

•Lead troubleshooting efforts on HVAC, boilers, pure steam generators, autoclaves, lab washers, RODI, refrigeration, electrical, plumbing, and pneumatic systems.

•Operate, maintain, and support mission-critical IT data center infrastructure including Computer Room Air Conditioning (CRAC) units, Uninterruptible Power Supplies (UPS), and battery strings.

•Complete preventative maintenance on equipment and building systems as established in department procedures.

•Available for emergency on-call rotation.

•Provide guidance, training, and mentorship to junior and senior technicians; serve as working shift lead.

•Author and own GMP quality records including Change Controls, Deviations or Problem Reports, CAPAs, and Methods of Procedure (MOPs).

•Author and revise Standard Operating Procedures, Preventive Maintenance procedures, job plans, and work instructions.

•Review and approve work order closure quality for completeness, accuracy, and GxP compliance before record submission.

•Serve as facility and utility subject matter expert during regulatory inspections and internal audits.

•Monitor critical plant systems through rounds, meter readings, Client trend reviews, and field inspections.

•Perform and document daily meter readings and trend utility performance data.

•Maintain accurate records of building operations, repairs, parts, equipment condition, and PM activities within the CMMS.

•Act as power user of the site CMMS for work order management, PM scheduling, job plan revision, and asset records.

•Act as power user of the site Client for alarm monitoring, trend review, and graphic verification.

•Coordinate planned work in server room spaces with site IT, ensuring Change Controls are in place for any activity affecting mission-critical systems.

•Approve contractor work Products and Job Safety Analyses; escort contractors in GMP, R&D, Warehouse, and data center areas; verify completion and quality of contractor work.

•Represent Facilities Maintenance on commissioning and qualification (IQ, OQ, PQ) of new and modified utility, facility, and mission-critical systems.

•Identify recurring failures, develop reliability reports, and recommend improvements to maintenance strategies, spare parts, and PM frequencies.

•Recommend capital and operating budget items including parts and equipment replacement planning.

•May perform other related duties as required and/or assigned.

•Ensure continuous operations of the site HVAC, utility, and mission-critical IT systems.

Minimum Qualifications (must have):

Experience/Requirements:

•Must have at least 10 - 12 years of related facilities or utilities maintenance experience in a GMP-regulated biotechnology, pharmaceutical, or life sciences manufacturing site.

•Must have demonstrated experience supporting at least two of the following GMP operating environments: GMP manufacturing, R&D laboratories, and warehouse or distribution facilities.

•Must have a proven working knowledge of electrical, plumbing, HVAC, and refrigeration equipment and systems.

•Must have demonstrated experience independently authoring and closing GMP quality records, including Change Controls, Deviations or Problem Reports, CAPAs, and Methods of Procedure (MOPs).

•Must have demonstrated experience as a working shift lead, crew lead, or team lead, including assigning daily work and providing technical direction to other technicians.

•Must comply with FDA, EH&S, cGMP, and ISO regulations.

•Must have advanced troubleshooting skills.

•Must have a strong working knowledge of the site Building Management System (Client) and Computerized Maintenance Management System (CMMS).

•Must have experience supporting emergency response, critical system recovery, and after-hours or on-call maintenance response.

Education:

•Must have a high school diploma or equivalent.

•Must have technical certification in multiple relevant mechanical and/or electrical trades.

•Prefer current EPA Section 608 Universal CFC certification.

•Prefer current OSHA 10-hour General Industry certification.

•Maryland 2nd Grade Stationary Engineer license required; Maryland 1st Grade Stationary Engineer license strongly preferred.

•Must have a valid driver's license.

Preferred Qualifications:

•Maryland 1st Grade Stationary Engineer license.

•OSHA 30-hour General Industry certification.

•NFPA 70E Qualified Electrical Worker training.

•Hands-on experience with Blue Mountain RAM (Regulatory Asset Manager) or equivalent validated GMP CMMS as a power user.

•Hands-on experience with Client Desigo Insight, Client Desigo CC, Johnson Controls Metasys, Client, or equivalent Client platforms.

•Hands-on experience with mission-critical data center infrastructure (CRAC, and UPS platforms).

•Experience with commissioning and qualification (IQ, OQ, PQ) of utility systems in a life sciences environment.

•High Pressure Boiler operator license and Low Pressure Boiler operator license.

•Forklift, scissor lift, aerial lift, and powered industrial truck certifications.

•PLC troubleshooting experience (Allen-Bradley, Client S7, or equivalent).

•MOP and SOP / technical writing experience preferred.

•Ability to develop reliability reports to assist in identifying areas of concern that could develop into future problems.

•Soft skills: communication (oral and written), problem solving, demeanor, pace, influencing, leadership, and negotiating skills.

•Ability to work independently, in a group setting, with little direction, or with direct supervision.