Bioengineering, Biotech and Pharmaceutical, Chemistry, Cleanroom, Control Systems, Current Good Manufacturing Practice (cGMP), Detail Oriented, Documentation, Equipment Maintenance/Repair, File Maintenance, High School Diploma, Maintain Compliance, Mathematics, Microbiology, Operational Communications, Operations Management, Operations Processes, Pilot Plant, Record Keeping, Safety Compliance, Safety Training, Standard Operating Procedures (SOP), System Operations, Team Player, Time Management, Training Program
Bio-Process Associate 1st shift
This role is in Devens, MA
100% Onsite
Please refer to attached Sample Schedule for specific days/hours work
Job Responsibilities:
Operates control systems and processes in Biotechnology Pilot Plants as assigned.
Prepares process buffers and reagents. Cleans equipment and maintain area in clean and orderly fashion.
Recognizes and reports safety, maintenance and operational variances to area management.
Communicates status of operations to area management in a timely manner.
Follows detailed SOP's and batch records.
Ensures compliance with cGMP and safety requirements.
Maintains files, records and equipment.
Records data, logs activities and monitors processes.
Achieves and maintains proficiency through training.
Education and Experience Required:
High school diploma with a minimum of 5 years process operations experience A.A.S. or B.S. degree is preferred.
Prior job related experience required along with demonstrated mechanical aptitude.
Familiarity with general chemistry, mathematics, microbiology and cGMP clean room operations is a plus.
Keen attention to detail.
Prior experience following and documenting written instructions is required.
Committed team player prepared to work in and embrace a team based culture
Shift work and overtime required.
Additional Requirements:
Selected candidates will be required to enter a structured training program and successfully complete all modules including Biologics orientation training, general knowledge training and job function training and successfully complete training module evaluations at 1, 3, 6 and 12 month milestones.