Manufacturing Lab Technician

Our client, a growing medical device company focused on redefining the treatment of spinal cord injury, is currently seeking a Manufacturing Lab Technician for a contract position with the potential to convert to permanent. This person will be responsible for the hands-on aspects of manufacturing of clinical investigational and/or commercial products following FDA regulations as well as contributing to the development of new products and processes.

 Responsibilities:

  • Hands-on manufacturing of bio-absorbable medical devices.

  • Hands-on chemical synthesis of bio-absorbable polymers and/or polymer conjugations in a laboratory controlled cGMP setting.

  • Develop, write, and review Standard Operating Procedures (SOPs), Manufacturing Instructions (MIs) and Manufacturing Batch/Device History Records (DHRs) for producing clinical investigational products and/or commercial products as needed.

  • Assist in procuring, installing, operating, qualifying, and validating (as applicable) all required equipment for producing clinical investigational and/or commercial products and medical devices.

  • Assist in the development, design, improvement, qualification, and validation (as applicable) of manufacturing processes and associated tooling/equipment using Good Manufacturing Practices.

  • Ensure safe handling of raw materials and hazardous waste. 

  • Support risk analysis reviews of materials, processes, and products.

  • Assist in the coordination of engineering and/or facility projects including facility expansion and maintenance as needed. 

  • Assist in the development, designing, planning, implementation, and statistical analysis for Design of Experiments (DOEs) to support the development, qualification, and validation (as applicable) of new products, processes, equipment, and tooling is beneficial.

Qualifications:

  • Bachelor’s of Science (BS) in Chemistry, Chemical/Biomedical Engineering, or similar science/engineering degree with 1-3 years of experience.

  • Able to perform manufacturing operations in cleanrooms producing medical devices and combination products which may include chemical processing steps.

  • Able to perform chemical reactions and polymer manufacturing processes in a controlled cGMP laboratory setting.   

  • Proficient computer skills (MS Outlook, Word, Excel, Teams) are preferred.

  • Knowledge of FDA Good Manufacturing Practices (GMP) regulations is beneficial.

  • Capability to work independently as well as on a team in start-up environment.

  • Must have a willingness to learn new skills concerning medical devices and/or combinational device manufacturing processes.

 

If you are interested in this position, please send your resume to apowell@daleyaa.com

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