Berkshire Sterile Manufacturing
Position Summary The Maintenance Technician is responsible for the repairs and maintenance of the facility and equipment and achieving departmental objectives. This individual will work on electro mechanical equipment such as Autoclaves, Isolators, Filling Equipment, and Cappers. Duties and Responsibilities…
Position Summary The Validation Engineer is responsible for assisting in the development, execution and approval of all validation programs and lifecycle documentation, e.g. SOPs, Change Controls, CAPAs, Deviations, ensuring compliance with in house specifications, standards and procedures and implementing industry…
Position Summary The CSV Technician will manage electronic data in a regulated manufacturing/laboratory/clinical environment in compliance with FDA 21 CFR 11 or other regulatory guidelines using the GAMP lifecycle framework, administer the BSM help desk, and provide technical assistance for…
Position Summary The Quality Control Analytical Associate performs laboratory testing and administrative tasks for the QC department. Testing includes incoming materials, in process samples, finished good and stability samples. It also includes performing experiments for method transfers, qualifications and validation.…
Position Summary Perform all production operations in the areas assigned within the facility. Perform production support operations in areas assigned and support start up, changeovers and tech transfer activities. Duties and Responsibilities Operate glass washers and autoclave Prepare buffers, medias…
Position Summary Perform all formulation operations in the area of assignment and support start up/changeovers/tech transfer activities. This position works under the immediate direction of the Formulation Supervisor and all work is conducted following a high standard of GMP compliance…
Position Summary The Director of Manufacturing balances the urgency of daily shift operations with the pursuit of long term goals while ensuring the highest standards of quality and compliance. Work requires excellent teamwork, ability to communicate clearly, and cooperate with…