Manufacturing Technical Associate - 2nd Shift

Manufacturing Technical Associate - 2nd Shift

Onsite in Fall River, MA

Full-Time

2nd shift 3:00pm - 11:30pm. Rotating shifts - 4 on 3 off - 3 on - 4 off

• Must be willing to work in a pharmaceutical manufacturing setting, including classified and controlled environments supporting Respiratory Metered Dose Inhaler (MDI) manufacturing.
• Execute manufacturing and packaging processes in accordance with Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), cGMP regulations, safety requirements, and established work instructions.
• Operate, set up, adjust, monitor and troubleshoot MDI manufacturing and packaging equipment, including filling, crimping, propellant charging, leak testing, inspection, and packaging systems.
• Perform routine manufacturing activities while achieving established production, quality, and safety requirements.
• Perform equipment setup, startup, changeovers, line clearances, disassembly, reassembly, and cleaning activities in accordance with approved procedures.
• Troubleshoot routine mechanical, pneumatic, equipment, and process-related issues using established procedures, operating parameters, equipment manuals, and approved work instructions to minimize equipment downtime. (Including but not limited to: adjusting machine settings to maintain established operating parameters; clearing equipment jams, blockages, and material flow interruptions; performing equipment resets and startup recovery following alarms or process interruptions; troubleshooting filling, crimping, leak-testing, inspection, and packaging equipment performance issues.)
• Assisting with the investigation of recurring equipment issues and escalating complex electrical, automation, engineering, validation, or maintenance concerns to appropriate personnel.
• Monitor equipment performance and communication opportunities for operational improvements to management.
• Prepare rooms and equipment for manufacturing operations, including verification of calibration status, pressure differentials, environmental conditions, and equipment readiness.
• Ensure line clearance requirements are completed and documented before initiating manufacturing activities.
• Receive, transfer, verify, and reconcile manufacturing materials according to approved procedures and batch documentation.
• Complete production and equipment documentation accurately, legibly, and contemporaneously in compliance with cGMP requirements.
• Participate in troubleshooting activities, investigations, corrective action implementation, and continuous improvement initiatives as assigned.
• Assist with equipment qualification, validation, and commissioning activities as directed by management, Engineering, Validation, or Quality personnel.
• Assist with training and onboarding of manufacturing personnel on established equipment operation, setup procedures, and departmental practices.
• Ensure adherence to quality standards throughout all stages of manufacturing and packaging operations.
• Wear appropriate personal protective equipment (PPE) and follow respiratory manufacturing containment and safety requirements.
• Perform duties through the safe use of equipment according to Health & Safety procedures and equipment manuals.
• Flexible to work extended hours to meet manufacturing schedules when required.
• Maintain discipline and comply with company policies and procedures.
• Participate in safety-related programs, committees, and initiatives.
• Enforce and follow safety regulations and ensure work areas remain clean and inspection ready.
• Adhere to companies Safety, Health, and Environmental policies.
• Work under general supervision while performing assigned responsibilities independently within established procedures and approved operating parameters.
• Other duties as assigned by Manufacturing Management.

• Bachelor's degree in engineering, Industrial Technology, Pharmaceutical Sciences, Chemistry, Biology, Manufacturing Technology, or a related scientific or technical discipline.

• Minimum seven (7+) years of experience in pharmaceutical manufacturing, respiratory manufacturing, medical device manufacturing, or other regulated manufacturing environments.
• Demonstrated experience operating, setting up, troubleshooting, adjusting, and performing minor repairs on automated manufacturing equipment.
• Experience performing equipment changeovers, startup activities, line clearances, and production documentation in a cGMP environment.
• Respiratory, inhalation, aerosol, or…