Senior Technician I (Wed-Sat) - Norton, MA

Responsibilities include but are not limited to operation of production equipment in the area of weigh/dispense, solution preparation, chemical synthesis, cleavage and deprotection, UF/DF, HPLC, annealing, concentration and lyophilization. This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP) and Batch Records. Troubleshoot and resolve process and equipment related issues and interact with support groups to ensure production targets are met and product and process comply with cGMPs, EHS and corporate policies. Ensure all operations and documentation conform to cGMP standards and that all SOPs and batch records are maintained to reflect current manufacturing practices. Gain knowledge of and maintain status as a Qualified Trainer for synthesis or HPLC operation areas. Provide technical training to junior employees; meet and maintain training material requirements Be the SME for the synthesis or HPLC operation areas. This includes SOP, Unicorn methods, MBR, training material, and form ownership for the primary operation (synthesis or HPLC) and all supporting operations (buffer/column packing or solvent prep/column packing) Use technical writing skills to initiate and provide subject matter expertise for deviations, CAPAs and change controls as required. Identify and support implementation of continuous improvement projects. Create work orders as needed, and coordinate activities to prevent maintenance and calibration events from impacting schedule. Perform Batch Record, Logbook requests and review manufacturing documentation to ensure compliance. Propose and review documentation revisions. Carry out work in a safe manner, notifying management of safety issues and risks. Support execution of equipment qualification and review associated protocols. On-call support during off hours may be required. Must possess a mechanical and scientific aptitude and be able to clearly and thoroughly document all work on existing forms and records. Bachelors of Science (BS) degree preferred and a minimum of 4 - 6 years' experience in a regulated GMP facility. Minimum requirements may be substituted for the equivalent combination of education and experience in the industry. Safety and the ability to maintain a compliant, highly effective and efficient production environment is critical. High level of attention to details in both operations and documentation is required. Familiarity with Unicorn software is a plus.