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Packaging Operator With cGMP

Devens, MA 01434

Posted: 09/13/2023 Job Number: 24973572

Job Description

100% Onsite.
Shift hours: 6AM-6PM (12-hour shift- 2 on / 2 off then 3 on / 3 off.
Must be comfortable with handling patient blood and blood derived drug products as well as liquid nitrogen handling.

The pay ranges between $20.25 to $21.00 per hour.

Project Description:
  • The Cell Therapy Supply Chain Packaging Operation Associate brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs.
  • The incumbent must be enthusiastic, innovative, goal-oriented, flexible, able to work efficiently with safety and quality in mind and understand good manufacturing practices to support routine patient and/or healthy donor samples received, finished goods product labeling and packaging manufacturing operations, and finished goods product shipment for Cell Therapy.
  • Performs cGMP functions associated with packaging operations, including visual inspection, labeling, and cartoning to support operations described in standard operating procedures and batch records.
  • Performs receiving transitions for patient and/or healthy donor samples and shipments for finished goods product.
  • Performs room sanitization activities to maintain controlled environment compliance.
  • Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
  • Performing tasks consistently with the safety policies, quality systems, and GMP requirements.
  • Completing training assignments to ensure the necessary technical skills and knowledge.
  • Assisting in setting up packaging manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
  • Train others on SOPs, Work Instructions to successfully complete product packaging operations.
  • Executing daily unit operations schedule that includes people, product, and material flow across multiple shifts.
  • Additional duties, tasks, and responsibilities as assigned by the Supply Chain department.
  • The incumbent is responsible that all finished goods are packed in accordance with specifications and for completing all packaging documentation required before line start-up and during the packaging process.
  • This position must comply with all Security Guidelines, Environmental Health and Safety regulations and cGMP's.
  • Operates equipment, following all established CGMP and Safety regulations.
  • Set up packaging line.
  • Prepare packaging along with packaging documentation required.
  • Packaging of finished goods in accordance with specifications.
  • Performs line clearance and changeovers.
  • Verifies all components against the packaging order.
  • Completes packaging documentation required before line start-up and during the packaging process.
  • Inspects the quality and accuracy of all information printed during the packaging process.
  • Selects samples from lots and delivers them to Q.A. Following packaging procedures.
  • Performs statistical inspection of packed products.
  • Maintain good housekeeping through packaging and inbound receipt process.
  • Maintain accountability of components for reconciliation.
  • Disposes waste to be recycled.
  • Replace other packaging operators as necessary.
  • Detect discrepancies during the packaging process.
  • Receives in patient incoming blood .
  • Processes patient incoming blood for manufacturing .
  • Utilizes computer systems such as SAP and MES to perform daily functions - experience no required, will train .
  • Gowning required - proper PPE will be worn .
  • Performs Apheresis material receipt and processing .

Required Skills:
  • High school diploma and or GED equivalency.
  • 1-3 years of experience in cGMP manufacturing within a biopharmaceutical or related field.
  • Experience in electronic batch records preferred.
  • Driven and motivated individual to learn and execute Final Product Packaging operations.
  • Must have the ability to work assigned shifts (Day, Night).
  • Must have the ability to work flexible hours, including weekends and/or Holidays, to complete work activities.
  • Must be able to work in a clean room environment and perform Final Product Packaging.
  • Must be comfortable being exposed to human blood components.
  • Must be able to work with temperature-controlled products.
  • Receiving and Shipping experience a plus.
  • Knowledge of inventory systems preferred.
  • The ability to read, write and verbally communicate in English.
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.

  • Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time throughout the day.
  • Carrying weight, Pushing, Pulling, Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
  • Climb - Required to climb (use of stepladders in production areas or stairwells) several times a day.
  • Bend and Kneel - Required to bend or kneel several times a day.
  • Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.
  • Moving Head and Neck Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day.
  • Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day.
  • Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day.
  • Will be required to wear personal protective equipment (PPE) and other clean room garments daily.
  • This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full full-body gowns, hairnets, gloves, and hearing protection.

This 6+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Malika: malika@alphaconsulting.Com



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Malika Peguero

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