Process Mechanic

Title: Process Mechanic Location: Exton, PA Duration: 12+ Months Pay Range: $22/hr - $25/hr Job Summary Under general direction, the Maintenance Mechanic is responsible for monitoring and operating GMP and non-GMP utilities and HVAC equipment, as well as performing preventive and corrective maintenance on utility and process-related equipment. Systems include, but are not limited to, plant steam, clean steam, chilled water, cooling towers, compressed air systems, and pharmaceutical-grade water systems (WFI) under GMP operation. Analyzes results and may develop testing and maintenance specifications for new and existing equipment. Prepares reports with recommendations for technical solutions. The ability to function in a fast-paced, highly technical environment and communicate effectively is essential. This position requires weekend on-call rotation and occasional off-hour emergency response. Essential FunctionsMaintain GMP and non-GMP utilities related to the pilot plant and R&D facility.Perform preventive and corrective maintenance on process-related equipment and maintain spare parts inventory for critical equipment.Schedule preventive maintenance and corrective work orders in collaboration with user groups.Develop and adhere to 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 departmental and inter-functional levels.Ensure adherence to cGMP, 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 within the R&D facility. Requirements " High School Diploma required; Associate s Degree or equivalent experience preferred. " Minimum of 5 years of experience in a cGMP Facilities department in an FDA-regulated industry with an Associate s Degree, or 7 years with a High School Diploma. " Prior experience in a GMP plant and familiarity with 21 CFR Part 11. " Knowledge of cGMP/EMEA and JP regulations. " Experience supporting FDA or other regulatory inspections/audits. " Experience with CMMS software. " Working knowledge of Client operating systems and proficiency in MS Office applications. " Ability to prioritize and manage complex, competing projects. " Strong problem-solving and reasoning skills. " Demonstrated ability to deliver effective troubleshooting solutions under tight timelines while maintaining composure and performance. " Effective interpersonal, written, and verbal communication skills. Physical & Other Requirements " Limited handling of laboratory equipment, chemicals, and biological materials. " Frequent standing, walking, use of hands and fingers, handling tools and controls, reaching, climbing, balancing, stooping, kneeling, crouching, crawling, talking, and hearing; occasional sitting. " Ability to frequently lift and/or move up to 50 pounds. " Weekend on-call rotation and some off-hour emergency response required.