Manufacturing Operator

Summary of Primary Responsibilities:

The Manufacturing Operator is responsible for performing manufacturing operations for the production of commercial medical device and drug products according to cGMP regulations.

Specific Responsibilities:

  • Perform Manufacturing procedures inside class 10,000-100 clean room in accordance to established SOPs, cGMPs, and safety regulations.
  • Complete the set-up, operation, disassembly, and cleaning of process equipment according to standard operating procedures.
  • Complete the preparation and execution of equipment and materials for autoclaving.
  • Operate laboratory instruments such as balances, pH meters, conductivity meters, mixers, autoclaves, etc.
  • Execute and witness batch record instructions during cGMP operations.
  • Document production activities according to GDPs in corresponding batch records and log sheets.
  • Initiates Quality exception paperwork involving root cause investigations.

Job Complexity:

Works on assignments that are routine or semi-routine in nature where ability to recognize deviation from accepted practice is required.  Normally receives general instructions on routine work, detailed instructions on new assignments.

Supervisory Responsibilities:


Experience, Knowledge, and Skills Required:

  1. Requires a high school diploma.
  2. 2+ years related experience in a manufacturing environment
  3. Knowledge of GMP documentation and regulations
  4. Basic computer skills including the ability to input data, prior experience with computerized control panels preferred
  5. Ability to communicate verbally and read, comprehend and prepare documents in English
  6. Able to lift and move equipment into place with and without assistance

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