Director Vial Inspector Jobs (NOW HIRING)

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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