Halo Pharmaceutical |

Whippany, New Jersey Department:

Pharmaceutical Manufacturing /

Engineering Employment Type:

Full-Time |

On-Site Location:

Whippany, NJ Environment:

Sterile Injectable / Aseptic Fill-Finish Position Summary Halo Pharmaceutical is seeking an experienced Aseptic Fill/Finish Mechanic to support sterile injectable manufacturing operations at our Whippany, New Jersey facility. This role requires hands-on experience with aseptic pharmaceutical manufacturing, Fill/Finish equipment, equipment troubleshooting, maintenance, and reliability. Sterile injectable / aseptic Fill-Finish experience is required. Direct experience with Groninger Fill/Finish systems and SKAN Isolators is highly preferred; candidates with comparable sterile filling and pharmaceutical isolator technologies will also be considered. Key Responsibilities

• Operate, maintain, troubleshoot, and repair aseptic Fill/Finish equipment used for sterile injectable manufacturing.
• Support automated filling equipment for vials, prefilled syringes, and/or cartridges.
• Perform preventive and corrective maintenance on filling equipment, pumps, needles, conveyors, stoppering systems, sensors, and related components.
• Operate and maintain pharmaceutical isolator systems, including H₂O₂/VHP bio-decontamination cycles and glove integrity testing.
• Support equipment setup, changeovers, troubleshooting, and change-parts activities.
• Support IQ/OQ/PQ, media fills, process validation, and equipment qualification activities.
• Troubleshoot basic mechanical, electrical, PLC/HMI, pneumatic, and automation-related equipment issues.
• Execute and document maintenance activities through the site CMMS.
• Support Root Cause Analysis (RCA), deviations, CAPAs, and equipment-related investigations.
• Maintain accurate maintenance records and documentation in accordance with cGMP and FDA requirements.
• Collaborate with Manufacturing, Engineering, Validation, Quality, and equipment OEMs. Required Qualifications
• 5+ years of hands-on equipment maintenance experience in pharmaceutical, biotechnology, medical device, or another highly regulated manufacturing environment.
• Direct experience with sterile injectable and/or aseptic Fill/Finish manufacturing is required.
• Hands-on experience with automated vial, syringe, or cartridge filling equipment.
• Experience with aseptic isolator or Restricted Access Barrier System (RABS) technology.
• Strong mechanical troubleshooting and equipment maintenance capabilities.
• Experience performing preventive and corrective maintenance in a cGMP environment.
• Working knowledge of aseptic processing, ISO 5 / Grade A environments, and cleanroom operations.
• Experience with CMMS systems and GMP maintenance documentation.
• Ability to read technical manuals, equipment drawings, schematics, and maintenance procedures. Highly Preferred Equipment Experience
• Groninger Fill/Finish systems, including UFVN FlexFill or similar Groninger platforms.
• SKAN pharmaceutical isolators or comparable aseptic isolator technology.
• Automated filling systems for prefilled syringes, cartridges, and vials.
• H₂O₂/VHP isolator bio-decontamination systems.
• WFI/PW systems, autoclaves, parts washers, and other sterile manufacturing equipment.
• PLC/HMI troubleshooting and automated pharmaceutical equipment.

Equivalent experience with other leading sterile Fill/Finish and isolator technologies will be considered. Education Associate degree or technical certification in Mechanical, Electrical, Industrial, Automation, Mechatronics, or a related technical discipline preferred. Equivalent hands-on pharmaceutical equipment experience may be considered in lieu of a degree. Work Environment This is an on-site position in Whippany, New Jersey, supporting a sterile injectable manufacturing environment. Candidates must be comfortable working in classified cleanrooms requiring full aseptic gowning and must be available to support equipment maintenance during manufacturing campaigns, shutdowns, and occasional weekend or off-hour requirements. Ideal Candidate A hands-on pharmaceutical mechanic or equipment technician with direct experience in aseptic filling equipment within a sterile injectable manufacturing environment and a strong understanding of equipment reliability, contamination control, aseptic processing, and cGMP compliance. Sterile injectable / aseptic Fill-Finish experience is an essential qualification for this position. Halo Pharmaceutical is an Equal Opportunity Employer.

Pay:

$50.00 per hour

Work Location:

In person