Utility Regulatory Analyst Jobs in Delaware (NOW HIRING)

We are seeking a highly skilled and proactive Lead Maintenance Mechanic to serve as the primary technical expert for the operation and maintenance of utilities and facility systems at our pharmaceutical manufacturing facility in Middletown, DE. Reporting to the Electrical Control & Equipment Maintenance Manager, this multi-craft role combines advanced maintenance strategies and mechanical troubleshooting with the rigorous documentation standards of the cGMP environment. The successful candidate will be responsible for the execution of preventive/predictive maintenance, troubleshooting complex equipment failures, and ensuring the continuous, safe operation of critical plant infrastructure to support life-saving production goals.

Responsibilities

• Multi-Craft Maintenance: Perform routine & corrective maintenance on utilities & facilities equipment, including Boilers, Deaerators, Chillers, Cooling Towers, Air Compressors, Process Water Systems, Pumps, Seals, Exchangers, Generators etc.
• Critical Utilities: Monitor & maintain water purification systems, clean steam generators and HVAC utilizing Building Management & Environmental Monitoring Systems.
• Reliability Execution: Execute Preventative/Predictive Maintenance tasks, including assisting with thermography, vibration analysis, data collection, oil sampling etc.
• Emergency Response: Serve as first responder for utility alarms and equipment failures.
• Contractor Oversight: Provide on-site escort and technical over-the-shoulder supervision for specialized vendors. Execute permitting procedures & coordinate daily maintenance/operational tasks.
• Complete work orders in the CMMS with high detail, ensuring all parts used and tasks performed are documented for regulatory compliance.
• Spare Parts & Tooling Management: Maintain the physical organization of the utilities shop and spare parts inventory; identify and request restock of critical components.
• Safety Leadership: Actively participate Hazardous Energy Control Procedures & Lock-out/Tag-out program. Execute Safe Work Permitting for contractors.
• System Optimization/Energy Management: Assist the maintenance management in identifying equipment trends or recurring failures and suggest mechanical or operational “Continuous Improvements”.
• Process Improvement: Progressively identify and propose Continuous Improvements to equipment or workflows that enhance yield, reduce ergonomic strain, decrease setup time, etc.

Regulatory Compliance & Documentation

• Good Documentation Practices: Execute and review documentation in real-time. Ensure compliance with attributable, legible, contemporaneous, original and accurate input.
• Capture & maintain accurate records of all maintenance activities, work orders, SOPs, calibration, and validation reports through the CMMS.
• Assist in the execution of qualification and validation protocols for new facilities/utilities equipment.
• Support Maintenance Management during regulatory audits by retrieving logs and explaining maintenance histories.
• Standard Operating Procedures: Lead the drafting and periodic review of SOPs & Drawings, ensuring they reflect current Good Manufacturing Practices.
• Audit Readiness: Maintain the production suites in a constant state of "inspection readiness" for FDA, DEA, internal and client-led quality audits.

Team Leadership & Training

• Serve as a technical mentor as the maintenance team expands, providing on-the-job training to junior personnel.
• Collaborate daily with Production and Quality teams to ensure equipment availability aligns with the manufacturing needs.
• Assist in the drafting and "red-lining" of Standard Operating Procedures & As-Built Drawings.
• Collaborate & Coordinate with Vendors for Equipment Specific Training.
• Participate in the execution of change controls.

Continuous Improvement & Cost Management

• Identify opportunities for energy reduction & continuous improvement. (ex. Identifying/Repairing Leaks, optimizing chiller sequences, improving maintenance-operations sequences).
• Participate in Root Cause Analysis (RCA)meetings to prevent the recurrence of mechanical failures.
• Support the implementation of the computerized maintenance management system by providing accurate field data and feedback on system operability.
• Provide technical subject matter expertise on equipment & consumables. Address standardization and identify cost saving opportunities.
• Support Environment, Health & Safety through active participation in the Emergency Response Program.

Qualifications

• High School Diploma or GED
• 3+ years of hands-on maintenance experience in a Pharmaceutical, Biotechnology, or highly regulated industrial environment.
• Technical Proficiency: Strong mechanical/electrical troubleshooting skills (pumps, motors, valves, AHUs, Boilers, Chillers, 480V/3-phase distribution and Medium Voltage control logic).
• GMP Knowledge: Demonstrated understanding of working in cleanroom environments and following strict gowning and documentation protocols.
• System Experience: Familiarity with building control systems and interfacing equipment.
• Software: Basic proficiency in Microsoft Office and experience using a Computerized Maintenance Management System (CMMS).
• Communication/Technical Writing: Ability to clearly & professionally communicate technical issues to non-technical stakeholders in-person & through electronics communications. Able to proficiently write technical subject matter for communications with engineering. 

Physical Requirements:

• Must be able to work in a plant environment with variable noise levels.
• Ability to wear appropriate PPE, including respirators and cleanroom "bunny suits."
• Ability to stand/sit/walk for long periods of time.
• Ability to lift 50 lbs. occasionally.
• Ability to crouch, bend, twist, and reach in tight mechanical spaces.
• Ability to climb ladders, stairs, and scaffolding to access rooftop equipment.
• Ability to work in various environments (boiler rooms, refrigerated storage, and outdoors).
• Clarity of vision and ability to identify/distinguish color-coded wiring and piping.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.