Aseptic Mechanic â Fill/Finish & Equipment Reliability Coordinator

A contract development and manufacturing organization that specializes in producing topical, semi-solid, and liquid pharmaceutical products for both prescription and over-the-counter markets. It supports clients through formulation, scale-up, manufacturing, and packaging, with a strong focus on quality, regulatory compliance, and speed to market. Key Responsibilities Aseptic Fill/Finish Equipment Operations & Maintenance  Support installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities of sterile injectable manufacturing.  Operate, maintain, troubleshoot, and repair the Groninger UFVN FlexFill filling line including syringe, cartridge, and vial filling modules.  Perform preventive maintenance (PM), corrective maintenance (CM), and change parts management on all Fill/Finish equipment components including pumps, needles, conveyor systems, stoppering heads, and inspection units.  Operate and maintain the SKAN Isolator system, including H2O2 bio decontamination cycles, glove integrity testing, HVAC/differential pressure management, and Grade A environmental monitoring.  Support container closure integrity (CCI) testing, leak detection, and visual inspection processes.  Collaborate with validation, quality, and manufacturing teams during media fills and process validation campaigns. CMMS & Equipment Reliability Coordination  Serve as the area CMMS super user and coordinator for the sterile manufacturing zone, managing all work orders, PM schedules, spare parts inventory, and equipment records within the CMMS platform.  Develop, implement, and continuously improve the preventive and predictive maintenance (PPM) program for all sterile manufacturing assets, including Fill/Finish lines, assoicated HVAC systems, isolators, WFI systems, parts washer, autoclaves, and other utilities.  Track and analyze equipment downtime metrics, Mean Time Between Failures (MTBF), Mean Time to Repair (MTTR), and Overall Equipment Effectiveness (OEE); report KPIs to engineering leadership.  Maintain accurate and audit-ready equipment history files, calibration records, and maintenance logs in compliance with FDA 21 CFR Parts 211 and 820.  Coordinate spare parts procurement with procurement/supply chain to ensure critical spare availability and minimize unplanned downtime.  Lead or support Root Cause Analysis (RCA) for equipment failures using methodologies such as 5-Why, Fishbone, or FMEA. $45.00 $50.00/hr Education  Associate's degree or higher in Mechanical, Electrical, or Industrial Engineering Technology, or a related technical discipline. Equivalent experience may be considered in lieu of degree. Required Experience  5+ years of hands-on mechanical maintenance experience in a pharmaceutical, biotech, or medical device manufacturing environment operating under cGMP conditions.  Direct, demonstrated experience with Groninger Fill/Finish equipment (UFVN FlexFill or equivalent Groninger platform) is strongly required.  Direct, demonstrated experience with SKAN Isolator systems or equivalent pharmaceutical-grade isolator technology is strongly required.  Proficiency with a CMMS platform (e.g., SAP PM, Maximo, Blue Mountain RAM, or equivalent); experience as a CMMS coordinator, super user, or administrator preferred.  Working knowledge of aseptic manufacturing principles, ISO 5/Grade A cleanroom environments, and sterile manufacturing operations.  Experience with IQ/OQ/PQ validation protocols and GMP documentation practices.  Familiarity with FDA 21 CFR Part 211 (cGMP for Finished Pharmaceuticals) and/or relevant Health Canada regulations. By applying for this job, you agree to receive calls, Al-generated calls, text messages, or emails from Synerfac Technical Staffing and our contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undeliverable messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at www.synerfac.com/privacy/