Maintenance Mechanic

Overview

Under general direction, the Maintenance Mechanic is responsible for monitoring, operating, and performing preventive and corrective maintenance on GMP and non-GMP utilities, HVAC systems, and process-related equipment. Responsibilities include supporting systems such as plant steam, clean steam, chilled water, cooling towers, compressed air systems, and pharmaceutical-grade water systems (WFI) under GMP operations.

The role involves analyzing equipment performance, developing testing and maintenance specifications, preparing technical reports, and recommending solutions to operational issues. The ideal candidate must thrive in a fast-paced, highly technical environment and demonstrate strong communication skills.

This position requires participation in weekend on-call rotations and occasional off-hour emergency response.

• Maintain GMP and non-GMP utilities supporting pilot plant and R&D facilities.
• Perform preventive and corrective maintenance on process-related equipment.
• Manage spare parts inventory for critical equipment.
• Schedule preventive maintenance and corrective work orders in coordination with user groups.

• Develop, follow, and maintain SOPs and GMP documentation.
• Ensure compliance with cGMP standards, industry safety requirements, and OSHA guidelines.
• Support regulatory inspections and audits as required.

• Monitor and coordinate activities of external contractors involved in maintenance and calibration.
• Participate in departmental and cross-functional process improvement initiatives.
• Analyze equipment performance and develop maintenance/testing specifications.

• Work closely with:
• Upstream and Downstream Operations
• Support Operations
• Quality Assurance (QA)
• Quality Control (QC)
• Validation teams
• R&D Facility and other internal/external stakeholders

• High School Diploma (required)
• Associate Degree or equivalent experience (preferred)

• Minimum 5 years of experience in a cGMP Facilities department within an FDA-regulated industry (with Associate Degree), OR
• Minimum 7 years of experience in a cGMP Facilities department within an FDA-regulated industry (with High School Diploma)
• Experience in GMP manufacturing environments
• Familiarity with 21 CFR Part 11
• Knowledge of cGMP, EMEA, and JP regulatory requirements
• Experience with FDA or other regulatory agency inspections/audits
• Experience using CMMS software

• Working knowledge of Microsoft operating systems
• Proficiency in MS Office applications

• Strong problem-solving and analytical skills
• Ability to manage multiple priorities and complex projects
• Excellent interpersonal, written, and verbal communication skills

• Limited handling of laboratory equipment, chemicals, and biological materials
• Frequent standing, walking, climbing, balancing, stooping, kneeling, crouching, crawling, and reaching
• Occasional sitting
• Frequent lifting or moving of up to 50 pounds
• Weekend on-call rotation and off-hour emergency response required