Process Mechanic – Sterile Filling & Packaging

WhiteCrow Research; Branchburg Township (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

A pharmaceutical manufacturing company located in New Jersey is seeking a Process Mechanic – Sterile Filling & Packaging to perform maintenance on equipment used in sterile environments. The ideal candidate will have 3+ years of experience and a technical background. Responsibilities include maintenance, troubleshooting, and ensuring compliance with safety regulations. This full-time role requires the ability to work flexible hours and a strong understanding of cGMP and aseptic techniques.

Qualifications

• 3+ years of experience as a mechanic or technician in a pharmaceutical, biotech, or sterile manufacturing environment.
• Experience with isolator‑based sterile filling equipment and cleanroom protocols is highly desirable.
• Strong mechanical aptitude with pumps, valves, conveyors, and packaging machinery.

Responsibilities

• Perform preventive and corrective maintenance on sterile IV bag fillers and related equipment.
• Support equipment setup, calibration, and changeover according to production schedules.
• Troubleshoot mechanical issues in real-time to minimize downtime.

Skills

Sterile liquid filling

Packaging equipment

Quality safety inspection

Electrical systems

Education

High school diploma or technical certificate

Associate’s degree in mechanical or technical field

Job description

Process Mechanic – Sterile Filling & Packaging

As a Process Mechanic – Sterile Filling & Packaging, you will be responsible for:

• Performing preventive and corrective maintenance on sterile IV bag fillers, isolators, compounding equipment, sterilizers, component prep equipment, automated inspection machines, and secondary packaging systems.
• Supporting equipment setup, calibration, and changeover in accordance with production schedules, maintenance plans, site SOPs, and cGMP requirements.
• Assisting in the installation, commissioning, and qualification of new sterile processing equipment, support equipment, and secondary packaging equipment.
• Troubleshooting mechanical issues in real-time to minimize downtime while maintaining aseptic conditions and operator safety.
• Ensuring proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.
• Documenting all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).
• Collaborating with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.
• Following all safety procedures, including lockout/tagout, confined space, and PPE use; actively contributing to a culture of workplace safety and compliance.
• Maintaining spare parts inventory, tools, and maintenance supplies in an organized and audit‑ready condition.
• Participating in training and cross‑functional activities to support plant startup and readiness for regulatory inspections.

What you already have...

• High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.
• 3+ years of experience as a mechanic or technician in a pharmaceutical, biotech, or sterile manufacturing environment.
• Experience with isolator‑based sterile filling equipment and cleanroom protocols is highly desirable.
• Strong mechanical aptitude and experience with pumps, valves, conveyors, pneumatic systems, and packaging machinery.
• Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.
• Working knowledge of cGMP, aseptic techniques, and safety regulations (OSHA, FDA, EU Annex 1).
• Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.
• Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).
• Self‑motivated with strong attention to detail, problem‑solving skills, and the ability to work independently or in a team.
• Willingness to work flexible hours, including weekends or off‑shifts during production or commissioning activities.
• Skills: Sterile liquid filling, packaging equipment, quality safety inspection, electrical systems.
• Hands‑on role in a cleanroom‑based pharmaceutical manufacturing facility with strict safety and aseptic requirements.
• Requires frequent gowning, standing, and work in confined or classified areas.
• Fast‑paced startup environment, requiring adaptability, initiative, and a collaborative mindset.
• Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.

Seniority level

• Associate

Employment type

• Full‑time

Job function

• Other

Industries

• Pharmaceutical Manufacturing