Job Description The Lab/Manufacturing Technician I will be responsible for the performance of manufacturing and materials processing and general testing for development, pilot, and cGMP aseptic manufacturing in accordance with well-defined standards and procedures. This individual will be expected to actively participate within the team and assist in creating a positive work environment. This individual may also provide support to other groups such as Quality Control, Quality Assurance and Research. This position will support both Operations and Development and work closely with other key stakeholders including Quality to perform and document manufacturing processes, support cGMP facility operations and upkeep and maintain cGMP compliance. 1 - 3 years of experience in aseptic biopharmaceutical manufacturing is required. Technician will be trained in bioprocessing procedures, and how to use and interpret analytical equipment and results. Some travel should be expected during the training period. Responsibilities:
Perform internal manufacturing, testing, labelling and packaging of intermediates. Serve as primary operator or as secondary verifier. Perform monitoring of facility, equipment and utilities to ensure uninterrupted operations. Ensure clear, documentation of all activities in accordance with current Good Manufacturing Practices to comply with regulatory requirements. Participate in batch record review as required by Quality and Production management Identify any issues and escalate to leadership and Quality Assurance. Work with leadership and team to address issues in a timely fashion. Support the ordering, handling, labelling and documentation of raw materials used for manufacturing of internal products. Provide support for manufacturing facility development, buildout, commissioning and qualification activities. Maintain the laboratory in a safe, clean, and orderly manner. Dispose and work alongside chemical and biohazardous material. Support and respond to after-hour alarms and/or other job critical tasks. Support operations and development in performing equipment calibration, certification and qualification, as appropriate, and maintain compliance with systems. Support compilation of manufacturing metrics, data, reporting and process improvements. Work with the Quality organizations as necessary to help investigate any excursions, deviations, CAPAs, etc and develop appropriate corrections. Stay current with company SOPs, batch records and industry standards, and all applicable regulations. Category: Manufacturing , Keywords: Manufacturing Technician Associated topics: bioengineering, biomaterials, biomechanics, bioprocess, bioprocessing, genetic, metabolic, molecular, neuro, pharmaceutical
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.