Process Mechanic

Job Responsibilities:

• Maintain GMP and non-GMP utilities related to the pilot plant and R&D facility.
• Perform preventive and corrective maintenance on process-related equipment.
• Maintain spare parts inventory for critical equipment.
• Schedule preventive maintenance and corrective work orders working with user groups.
• Develop and adhere to all SOPs and other GMP documentation as required.
• Monitor activities of outside contractors supporting maintenance and calibration activities.
• Participate in planning and process improvement activities at the departmental and inter-functional level.
• Ensure adherence of operations to cGMP as well as industry safety standards and OSHA guidelines.
• Interact cross-functionally with Downstream/Upstream Operations, Support Operations, Quality Assurance, Quality Control, Validation, and other internal and external functions.
• Prepare reports with recommendations for solutions to technical problems.
• Support plant systems including steam, clean steam, chilled water, cooling towers, compressed air systems, and pharmaceutical-grade water systems (WFI).

Skills:

• Experience in GMP plant operations and compliance with 21 CFR Part 11.
• Knowledge of cGMP/EMEA and JP regulations.
• Experience with inspections/audits by FDA or similar regulatory agencies.
• Proficiency in CMMS software and Microsoft Office applications.
• Strong troubleshooting, problem-solving, and reasoning skills.
• Ability to prioritize and manage complex and competing projects.
• Effective interpersonal, written, and oral communication skills.
• Ability to work under tight timelines and delivery pressures while maintaining composure.

Education/Experience:

• High School Diploma required; Associate’s degree or equivalent experience preferred.
• Minimum of 5 years working experience in a cGMP Facilities department in an FDA-regulated industry with Associate’s degree, or minimum of 7 years working experience with High School Diploma.
• Prior experience in a GMP plant environment.
• Physical Requirements:
• Frequent standing, walking, use of hands, reaching, climbing, balancing, stooping, kneeling, crouching, or crawling.
• Occasional sitting.
• Must frequently lift and/or move up to 50 pounds.
• Limited handling of laboratory equipment, chemicals, and biological materials.
• This position requires weekend on-call rotation and some off-hour emergency response.