This position will function in Repligen's OPUS Column Packing groups. Cross training into other departments may be required based on the changing needs of the department. The successful candidate will play a key role in ensuring that the department's production and quality goals are met. Applicants must have strong technical knowledge and problem solving skills. Must be able to follow oral and written instructions accurately, learn complex tasks quickly, and complete tasks in a timely manner
Experience working in a classified cleanroom, and knowledge of GMP/ISO/document controlled processes would be beneficial. Attention to detail, and the ability to work in a team environment are essential. Ability to read engineering drawings and be familiar with process control software is also highly desirable. Candidates must be willing and able to learn new manufacturing processes as the company grows and also to work overtime (including occasional weekends).
Responsibilities: • Cleaning, testing and assembly of multi-part plastic filter housing units in a classified cleanroom environment • Buffer and media preparation • Equipment and component cleaning and preparation • Assembly and packaging of prepared chromatography columns • Analysis of chromatography column performance • Execution of validation protocols • Timely and accurate completion/review of production documentation and maintaining of laboratory notebooks, summarizing results, tracking data in Microsoft Excel/Word • Compliance with all aspects of Repligen's IS09001Quality Management System • Entry of in-process data into trending databases • May be required to cross train into other departments based on the needs of the company
BS degree in a related field preferred and 1-2 years’ experience in Biotech manufacturing. Candidates without BS degree will be considered with 2 plus years' experience in Biotech manufacturing • Experience in column chromatography is preferred • Experience with the operation of laboratory equipment (including pumps, UV detectors, pressure tanks, and various gauges/sensors) and operation of process-scale manufacturing equipment. • Excellent organizational and communications skills • Must be resourceful and self-motivated.