Associate I, Manufacturing (Nights)

Thermo Fisher Scientific
Full time Full day
Cambridge, MA

Summary:


Operates equipment used to manufacture products. Weighs, measures and checks raw materials to ensure that batches manufactured contain proper ingredients in proper quantities. Perform basic operations to manufacture drug product injectables in a cleanroom environment and following GMP standards. Run equipment, pumps, and automated systems. Push fluids through filters in chromatography columns. Set flow paths for the operations, following SOPs and Batch records

Responsibilities:


  • Effectively execute work instructions while complying with procedures and cGMP regulations
  • Acquires job skills and learns company policies and procedures to complete routine tasks.

  • Achieving full training status associated with the department.

  • Works on assignments that are routine in nature, requiring limited judgment. Has little or no role in decision-making.

  • Receives detailed instructions on all work.

  • Stays up to date on required job training.

  • Operates automated and manual equipment and conducts associated activities such as sampling, material handling, cleaning and maintenance in accordance with Standard Operating Procedures, current Good Manufacturing Procedures and Safety guidelines.

  • Performs in-process tests (such as hardness, weight, variation, pH and moisture content) to ensure that batches meet specifications.

  • Execution of manufacturing batch records with focus on "right first time".

  • Adhere to the Quality Management Systems by living the Quality values every day and holds peers across the site accountable as well.

  • Assist in the completion and identification of PPI initiatives and continuous improvements.

  • Escalate problems instead of trying to fix on own.

  • Maintains a clean and safe work environment
  • Maintain a culture of safety by identification of near misses, safety walkthroughs and assisting with resolution of safety observations. Ensure chemicals are properly stored and labeled.

  • 90% of time spent on the floor


Education:


  • High school or STEM certificate preferred.

  • An equivalent combination of education and experience may be considered

Experience:


  • Related experience preferred but not required.


Knowledge/Skills:


  • Understand cleanroom concepts
  • Ability to follow directions & procedures and work in team environment. Strong attention to detail and drive to accomplish the job timely, accurately and safely the first time is required, as well as the ability to work closely and effectively in a team environment
  • This position will generally require the ability to work a 12-hour rotating shift in a 24-hour, 7 day per week operation to include evenings and holidays. Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.


Physical Requirements:


  • Employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk, or hear
  • The employee is required to walk and stoop, or kneel, crouch approximately 80% of the time
  • The employee is required to ascend/ descend stairs approximately 20% of the time, lift a maximum of 50 lbs., and sit for a maximum of 4 hours
  • Specific vision abilities required by this job include close vision and ability to adjust focus with tasks.

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