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Job Title
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Manufacturing Technical Associate - MDI - 2nd Shift
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Organization Name
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InvaGen Pharmaceuticals, Inc.
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Location
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Fall River, MA
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Employment Type
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Full Time
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Salary Range
(Base/salary)
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$ 30/hr - $40/hr
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Benefits
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In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance – medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) – vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits.
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Work Hours/ Shift/ Remote
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Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
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Responsibilities/ Accountabilities
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- 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 communicate 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 CIPLA's 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.
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Education Qualifications
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- Bachelor’s degree in engineering, Industrial Technology, Pharmaceutical Sciences, Chemistry, Biology, Manufacturing Technology, or a related scientific or technical discipline.
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Experience
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- 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.
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Skills/ Competencies
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- 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.
- Ability to train and assist coworkers on established procedures and equipment operation.
- Ability to prioritize work assignments and perform effectively in a fast-paced production environment.
- Strong analytical and problem-solving skills with attention to detail.
- Must communicate clearly and concisely across organizational levels, both verbally and in writing.
- Strong command of written and spoken English required.
- Proficiency with manufacturing systems, electronic documentation systems, and Microsoft Office applications.
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Physical Requirements
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- Ability to safely work in manufacturing areas utilizing hydrofluoroalkane (HFA) propellants, compressed gases, and other respiratory product components in accordance with established safety procedures and training requirements.
- Ability to wear required personal protective equipment (PPE), including safety glasses, gloves, hearing protection, respirators (if required), protective footwear, and cleanroom gowning for extended periods.
- Ability to stand and walk continuously for up to 12 hours per shift.
- Ability to frequently bend, stoop, crouch, kneel, reach, climb stairs, and work around manufacturing equipment.
- Ability to use hands and fingers to operate equipment controls, perform machine adjustments, assemble and disassemble equipment components, and complete routine equipment maintenance activities.
- Ability to visually inspect equipment, components, production materials, labels, and documentation for extended periods.
- Ability to lift, push, pull, and carry up to 50 pounds unassisted and heavier loads with appropriate material handling equipment.
- Ability to move pallets, drums, components, and manufacturing equipment using pallet jacks, drum handling devices, carts, and other approved material handling equipment.
- Ability to ascend and descend ladders and work platforms safely when performing equipment setup, inspections, cleaning, and changeover activities.
- Ability to perform repetitive tasks involving manual dexterity, including equipment assembly, disassembly, change-part installation, component replacement, and documentation activities.
- Ability to work in environments with varying temperatures, noise levels, and humidity conditions consistent with pharmaceutical manufacturing operations.
- Must be medically qualified to wear respiratory protection and other required PPE, as applicable.
- Should not have any restrictions that would prevent working with active pharmaceutical ingredients (APIs), excipients, propellants, cleaning agents, or other materials commonly used in respiratory pharmaceutical manufacturing while utilizing required engineering controls and PPE.
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