Chemical Manufacturing Technician

Job Description

Job Description

Reporting to the Production Supervisor, the Chemical Manufacturing Technician performs a wide variety of operations. The primary responsibility is executing and overseeing chemical manufacturing processes to ensure the highest quality and efficiency standards are met.

Fully comply with all of the requirements of the EN ISO 13485 : 2016, ExThera Medical Corporation standards and policies as well as applicable regulatory requirements including but not limited to Regulation (EU MDR) 2017 / 745, 21 CFR Part 820, Australian Therapeutic Goods (Medical Device) Regulations (TG(MD)R Sch3), Brazilian Good Manufacturing Practices (RDC ANVISA 665 / 2022), Japanese QMS Ordinance (MHLW MO 169), and Health Canada.

Key Responsibilities

• Responsible for accurately following the procedures and data recording that is required on the Production Document.
• Perform staging and transfer of required raw materials for the product to be made.
• Weighing and dispensing the required raw materials for the synthesis.
• Accurately record all raw materials used in the Material Log Sheet and the Production Document.
• Collect sampling and perform in-process monitoring of the synthesis.
• Perform equipment cleaning - making sure that the reactor and ancillary equipment is clean and ready for use.
• Accurately document all manufacturing activities, including batch records, deviations, and equipment logs in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
• Participate in continuous improvement initiatives to enhance manufacturing processes, optimize yields, and reduce waste.
• Follow all safety protocols and regulatory guidelines (e.g., FDA, ISO) to ensure a safe work environment and compliant manufacturing operations.
• Responsible, safe disposal of Hazardous Waste generated daily.
• Practice good housekeeping in the Manufacturing, Staging and Laboratory Areas using the 5S Methodology.
• Report any observed deviations or unsafe equipment, conditions or practice immediately to a supervisor, management or member of the Safety Committee.
• Comply with all ExThera Medical safety requirements, including posted placards, SOPs and the Safety Manual.
• Assist other personnel in daily Manufacturing or R&D duties.
• Perform repairs and preventative maintenance of manufacturing equipment.
• Ensure that assigned duties are performed according to schedule.
• Adhere to ExThera Medical Quality System procedures and ISO 13485 standards.
• Responsible for performing work activities in accordance with the procedures and requirements of ExThera Medical’s Quality Management System and Quality Policy and strive to achieve the Quality Objectives applicable to this position.

What you Bring

• Bachelor’s degree in Chemistry, Chemical Engineering, or related field preferred. Equivalent experience or technical training may be considered.
• Proven experience (5 years) in chemical manufacturing within the medical device industry or a similar regulated environment.
• Strong understanding of chemical processes and formulations.
• Proficiency in following SOPs and GMP guidelines.
• Ability to troubleshoot equipment and process issues effectively.
• Excellent attention to detail and organizational skills.
• Good communication skills and ability to work collaboratively in a team environment.

Relocation benefits are not offered for this role. The expected salary range for this position based on the primary location of Martinez, Ca is $58,240 to $62,450.

Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

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