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Aseptic Mechanic – Fill/Finish & Equipment Reliability Coordinator

Synerfac Technical Staffing

Whippany, NJ

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JOB DETAILS
SALARY
$45–$50 Per Hour
JOB TYPE
Temporary, Contractor
SKILLS
Analysis Skills, Asepsis, Biotech and Pharmaceutical, Calibration, Campaigns, Cleanroom, Code of Federal Regulations, Computerized Maintenance Management System (CMMS), Continuous Improvement, Contract Manufacturing, Conveyor Systems, Current Good Manufacturing Practice (cGMP), Customer Support/Service, Documentation, Electricity, Equipment Maintenance/Repair, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), GMP (Good Manufacturing Practices), HVAC, ISO (International Organization for Standardization), Identify Issues, Industrial Engineering, Leadership, Maintain Compliance, Manufacturing, Manufacturing Operations, Mechanical Maintenance, Medical Equipment, Metrics, Order Management, Organizational Skills, Performance Metrics, Preventative Maintenance, Process Validation, Project Portfolio Management (PPM), Pumps, Purchasing/Procurement, Regulatory Compliance, Root Cause Analysis, Supply Chain, Testing, Validation Plan
LOCATION
Whippany, NJ
POSTED
4 days ago
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.

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About the Company

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Synerfac Technical Staffing

HEADQUARTERS
Parsippany, NJ, USA