Manufacturing Associate

Bayside Solutions
November 13, 2021
Union City, CA
Job Type


Job Description

  • Support Manufacturing set-up, operation, troubleshooting and dismantling equipment used for the preparation of drug delivery systems. This includes executing experimental, clinical and process validation operations, including analytical measurement and basic data analysis.
  • Interact/Support Process and Equipment Engineering, System Design Engineering and Formulation personnel to provide product support.
  • Provide support for process and equipment validation activities for cGMP operations.
  • Demonstrate ability to recognize and document equipment malfunctions and process deviations.
  • Have technical ability to work on equipment and other special assignments
  • Assist with resolving technical issues as well as maintenance of production equipment.
  • Follow all relevant standard operating procedures and complete master production records in a cGMP environment.
  • Review existing operational and processes in manufacturing and provide technical expertise to improve procedures.
  • Review Batch/Lot material issuance for completeness/accuracy and perform Batch/Lot material reconciliation as required.
  • Complete and Review batch production records to ensure cGMP documentation practices are followed and information entered is complete and accurate. Develop/revise manufacturing associated documents.
  • Train newly hired technicians and assist in cross training of other less experienced technicians.
  • Provide communication between shifts to ensure smooth and efficient transition of tasks.
  • Bring equipment and facilities issues to the attention of the Supervisor for resolution.
  • Self-motivated and be able to work with minimal supervision. Have a hands-on approach to get the job done.


  • Bachelor's degree or equivalent with 2+ year relevant work experience required in the medical device field or Pharmaceutical/Biotech industry required. Aseptic manufacturing experience is highly desired.
  • Experience in classified clean room manufacturing operations is required.
  • The ability to work and communicate in a safety-conscious, dynamic, project-driven team focused environment is essential. Demonstrate to be a self-motivated individual and the ability to follow directions effectively.
  • Strong mechanical aptitude and familiarity or experience in handling drug compounds, organic chemicals and solvents is required. Demonstrated basic math skills.
  • Perform duties in accordance with Current Good Manufacturing Practices (cGMP's), FDA and ISO guidelines.
  • Excellent written and verbal communication skills. Must have computer skills including Microsoft Word and Excel.
  • Must be willing and able to work flexible hours and/or overtime when required; and demonstrate the ability to perform multiple operations and/or projects simultaneously.
  • Ability to sit or stand for long periods of time. The ability to lift 35-40 lbs. is essential.
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