Work Location: Hartford County, Connecticut

Summary:

The Production Technician supports sterile production lines and cleanroom operations, ensuring compliance with regulatory standards and maintaining high-quality manufacturing processes. This role involves aseptic filling, visual inspection, packaging, and operational support, with a focus on safety, documentation, and adherence to procedures.

Responsibilities:

• Perform aseptic filling, production, and packaging processes in compliance with established procedures and regulatory standards.
• Maintain continuous mental and visual attention to manufacturing functions, ensuring accuracy and quality throughout operations.
• Strictly adhere to Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Parts 210 & 211.
• Document and sign off on all work performed, ensuring traceability and compliance with quality standards.
• Clean and disinfect equipment, manufacturing areas, and cleanrooms following manufacturing activities and SOPs.
• Conduct visual inspections, categorize defects, and perform quality checks on ampoules, trays, and cartons as required.
• Prepare disinfectants, control cleanroom entry, and manage inventory for manufacturing and cleaning materials.
• Carry out additional duties as assigned by management to support production and operational needs.

Qualifications:

• Ability to perform sterile gowning, including balance and attention to detail, and wear plant-dedicated scrubs and shoes in cleanroom environments.
• Must pass sterile gowning and aseptic filling qualification tests to participate in cleanroom and manufacturing activities.
• Ability to spend up to 90% of manufacturing days fully gowned in Class 5 or Class 6 cleanrooms, including head covering, face mask, and goggles.
• No jewelry, make-up, or nail polish permitted in cleanroom; must be able to stand continuously for 3-4 hour periods.
• For visual inspection roles: must pass an annual eye exam and a visual inspection qualification test; able to lift ampoules to eye level and sit for extended periods.
• Physical ability to lift up to 40 lbs. and perform cleaning activities using mops and wipers; able to wear a full facemask as required.
• Adherence to all safety, documentation, and procedural requirements in a regulated manufacturing environment.
• High school diploma or equivalent preferred; prior experience in sterile manufacturing, cleanroom, or regulated production environments is a plus.

Published Category: Manufacturing & Technical Operations