Repligen Corporation Waltham , MA 02154
Posted 2 months ago
Overview
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.
Schedule: Monday through Friday, 3PM - 11PM
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
Candidates must be willing and able to learn new manufacturing processes as the company grows and also to work overtime (including occasional weekends)
May be required to cross train into other departments based on the needs of the company
Qualifications
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
Excellent organizational and communications skills
1-3 years' experience in Biotech manufacturing is preferred but not required.
Associate degree or certificate in biotechnology field is preferred but not required.
Candidates with high school diploma will be considered with 5 plus years' experience in Biotech manufacturing
Experience in column chromatography is preferred but not required
Experience with the operation of laboratory equipment (including pumps, UV detectors, pressure tanks, and various gauges/sensors) and operation of process-scale manufacturing equipment
Must be resourceful and self-motivated
Repligen Corporation