Aseptic Mechanic – Fill/Finish & Equipment Reliability Coordinator

Position Summary

Halo Pharmaceutical, a leading North American Contract Development and Manufacturing Organization (CDMO) and subsidiary of SK Capital Partners, is seeking a highly skilled Aseptic Mechanic – Fill/Finish & Equipment Reliability Coordinator to join our growing sterile injectable manufacturing team at our Whippany, New Jersey facility. This critical role supports the installation, operation, maintenance, and continuous reliability of our state-of-the-art Fill/Finish manufacturing line, including the Groninger UFVN FlexFill syringe,cartridge, and vial filling system and the SKAN Isolator platform. The incumbent also serves as the primary CMMS (Computerized Maintenance Management System) owner for the sterile manufacturing area, driving a proactive equipment reliability program that ensures maximum uptime, cGMP compliance, and operational excellence.

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 Flex Fill 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.
• Participate in equipment change control, CAPA development, and deviation investigations related to Fill/Finish equipment.

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, associated 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.
• Interface with original equipment manufacturers (OEMs), including Groninger and SKAN, for technical service visits, remote support, and spare parts management.
• Support GMP audit readiness and actively participate in internal audits, regulatory inspections, and third-party audits related to equipment and maintenance systems.

Documentation, Compliance & Quality

• Author and revise SOPs, maintenance procedures, batch records, and equipment logbooks in accordance with cGMP documentation standards.
• Ensure all maintenance and operational activities are documented in real-time and meet FDA, Health Canada, and DEA compliance requirements.
• Complete all required training, including aseptic technique, cGMP, safety, and equipment-specific certifications.
• Support environmental monitoring (EM) programs and clean-room compliance activities.

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 Flex Fill 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 clean-room 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.

Preferred Experience

• Experience in a CDMO environment supporting multiple product lines and clients.
• Exposure to controlled substance manufacturing (DEA Schedule II-V) and associated security/handling protocols.
• Background with WFI/PW system maintenance, autoclave/sterilizer operations, or lyophilization equipment.
• Six Sigma, Lean Manufacturing, or TPM (Total Productive Maintenance) certification or training.
• Experience with container closure integrity (CCI) testing methods (e.g., HVLD, vacuum decay).

Skills & Competencies

Aseptic Technique & Sterile Manufacturing-------------------- Proficient

Groninger UFVN FlexFill Operation &Maintenance ------------Proficient

SKAN Isolator Systems ----------------------------------------Proficient

CMMS Administration & Reliability KPI Reporting --------------Proficient

Root Cause Analysis (RCA / FMEA / 5-Why)--------------------Proficient

cGMP Documentation & Compliance -------------------------Advanced

Preventive & Predictive Maintenance -------------------------Advanced

GMP Audit Readiness -----------------------------------------Proficient

PLC / HMI Troubleshooting (basic)---------------------------- Proficient

Cross-functional Team Collaboration -------------------------Proficient

Physical & Environmental Requirements

• Ability to work in a clean-room (ISO 5-8 / Grade A-D) environment requiring full gowning per aseptic procedures.
• Ability to lift and carry up to 50 lbs and perform sustained periods of standing,bending, and manual equipment manipulation
• Willingness to work flexible hours, including weekend coverage, shutdown maintenance windows, and on-call support during critical manufacturing campaigns.
• Exposure to chemical agents used in pharmaceutical manufacturing, including H2O2 vapor, cleaning agents, and active pharmaceutical ingredients (APIs) including controlled substances.

Work Environment

This position is based on-site at Halo Pharmaceutical's Whippany, New Jersey facility. The role operates primarily within the sterile injectable manufacturing suite and associated support areas. The sterile injectable manufacturing program, supported by a significant capital investment, is scheduled for commercial launch in 2026 and represents a strategic growth platform for the organization.

Why Halo Pharmaceutical

Strategic Growth: Join a rapidly expanding CDMO at the forefront of sterileinjectable manufacturing in North America.

Cutting-Edge Technology: Work with best-in-class Groninger and SKAN equipment platforms from day one.

Regulatory Excellence: Operate within a facility recognized by FDA, DEA, HealthCanada, EMA, ANVISA, and MHRA.

Integrated Pipeline: Leverage Noramco Group API supply chain integration for end-to-end pharmaceutical solutions.

Career Development: Access cross-functional growth opportunities across formulation development, quality, validation, and operations leadership.

Halo Pharmaceutical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation,gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Employment is contingent upon successful completion of a background check, drug screening, and verification of eligibility to work in applicable jurisdictions.

Pay: $50.00 per hour

Work Location: In person

Salary : $50