Pharmaceutical Manufacturing Operator

1 week ago


Central Islip, United States FIS Recruitment Full time
Job DescriptionJob Description

Job description
Work Hours/ Shift

These are full-time positions, paid on an hourly basis, eligible for paid time-off and benefits for the following shifts:

Shift 1 - 7:00 AM – 3:30 PM

Shift 2 - 3:00 PM – 11:30 PM

OT required mornings and weekends.

 

Skills/ Competencies

  • Must have legible handwriting, and the ability to perform accurate documentation.
  • Understanding of granulation, compression, coating, and encapsulation machines.
  • Capable of conducting troubleshooting, investigations and root cause identification and analysis.
  • Able to prioritize, plan and work under tight schedules and deadlines.
  • Must possess strong documentation and technical writing skills and be able to apply relevant scientific principles and practices.
  • Must communicate clearly and concisely across levels, both orally and in written.
  • Strong command over written and verbal English is required.

 

Responsibilities/ Accountabilities

  • Must be willing to work in a pharmaceutical manufacturing setting.
  • Must be able to know how to operate pharmaceutical production machinery independently and thoroughly complete required documentation (legible writing, accurate reporting, maintain and file, etc.)
  • Execute procedures for manufacturing processes in accordance with batch manufacturing record (BMR) and Standard Operating Procedures (SOP) requirements.
  • Perform machine changeovers, cleaning and set up as per SOPs. Ensure the proper area & equipment cleanliness and setup in stipulated time.
  • Prepare a room and equipment for line clearance, replace room filters, Ensure verification and calibration of balance/scale and check pressure differential for the rooms.
  • Ensure line clearance before initiating manufacturing activities in each area.
  • Receive/transfer material from/to dispensing/manufacturing storage and check dispensed materials/final mix blend/compressed tablets and labeling as per BMR.
  • Wear appropriate personal protective equipment (PPE) as stated in the SOP/BMR before initiating the process.
  • Able to operate applicable equipment independently as per area of operation.
  • Ensure adherence to quality standards during all stages of the manufacturing process.
  • Complete manufacturing documents on time, ensuring accuracy and completeness.
  • Responsible for training on all relevant SOPs and always maintain compliance with related SOPs and current Good Manufacturing Practices (cGMP) in the manufacturing process.
  • Perform duties through the proper, safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
  • Flexible to work extended hours, to achieve manufacturing schedule when needed.
  • Maintain discipline and comply with company policies and procedures.
  • Perform entire duties as communicated time to time by department management/designee.
  • Participate in safety related programs and or safety teams as needed.
  • Enforce and follow safety regulations and ensure the working area is clean.
  • Adhere to Safety, Health, and Environmental policies.
  • Must be able to work under general supervision and able to work independently and in a team environment.
  • Must be able to exercise appropriate professional judgment on matters of significance.
  • Other duties assigned as required by Manufacturing Management.

 

Education Qualifications

  • High School Diploma or equivalent experience

Minimum three years of direct work experience in pharmaceutical manufacturing. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.


Physical Requirements

  • Should not have any restriction to work with powder containing active pharmaceutical ingredients.
  • This position requires the ability to do heavy lifting / bending frequently.
  • Long periods of standing up/walking during the working hours; ability to ascend/descend ladders; and able to lift to 35 pounds.
  • Must be able to move pallets/equipment weighing about 200 – 300 kgs using suitable moving equipment like pallet jacks.

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