Manufacturing Technical Associate - 2nd Shift
Aequor
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
Responsibilities
/ Accountabilities
Onsite in Fall River, MA
Full-Time
2nd shift 3:00pm - 11:30pm
Rotating shifts - 4 on 3 off - 3 on - 4 off
Responsibilities
/ Accountabilities
- 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 Metered Dose Inhaler (MDI) manufacturing experience preferred.
- Advanced knowledge of pharmaceutical manufacturing operations and cGMP requirements.
- Demonstrated ability to independently operate, set up, troubleshoot, adjust, and perform minor repairs on manufacturing equipment following approved procedures.
- Strong mechanical aptitude with working knowledge of pneumatic, electromechanical, and automated production systems.
- Ability to identify equipment issues, perform troubleshooting activities, and support root cause investigations using established problem-solving methods.
- Experience performing equipment changeovers, line setup, cleaning verification, and operational readiness activities.
- Ability to read and interpret SOPs, batch records, equipment manuals, technical drawings, and manufacturing documentation.
- Working knowledge of manufacturing process controls and equipment performance monitoring.
- Strong documentation skills with the ability to accurately complete production records and technical documentation.
Vacancy posted 9 days ago
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