Manufacturing Associate I

Independently executes all routine unit operations in Cell Culture including change-over procedures, scheduling within the shift team, equipment cleaning and set up, CIP, SIP and SIP of Bioreactors up to 12kL. Able to perform in-process testing such as cell counting, and BGA. Monitors and controls weights, flows, volumes, temperatures, pressure, and pH. Identify and report any issues related to manufacturing performance, process and safety to the team lead and assist in investigations of deviations in order to facilitate continuous process improvement. Train junior staff on unit operations such as bioreactors, cell separation, chromatography and tangential flow theory as well as CIP/SIP operations. All training will be conducted with an emphasis on safety and completion of operations in a timely manner. Collaborates within team and department in order to follow best practices and meet department goals. Report any issues related to manufacturing performance, process and safety to the manager in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement.

Experience working with established GMP procedures and bulk manufacturing. Technical knowledge of manufacturing systems, methods and procedures. Understanding of cell culture processes. Possess effective troubleshooting skills with equipment and/or process.
Demonstrated ability to be organized and work well in small work groups.
Must be able to assist in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.
Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
Detail oriented. Demonstrated ability to read, comprehend, and follow written instructions.
Demonstrated written and verbal communication skills are required.
Must be able to work in a team environment.
Experiences in related biotechnology/pharmaceutical industry strongly preferred
Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer based software
Preferred skills include experience in: Current Good Manufacturing Practices, Mammalian cell culture, Bio Manufacturing Execution System (BioMES), Process Control System DeltaV, Laboratory Management Information System (LIMS)
Physical Demands / Surroundings- Requires physical activity such as almost constant standing, walking, eyestrain, etc. Must be able to occasionally lift up to 25 lbs. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
Visual Demands - Position requires constant use of computer terminals and routine / repetitive work.
Temperaments/Mental Requirements- The position requires concentration as errors might cause minor to moderate delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
Level of Proficiency - Entry level in subject matter
Attendance / Schedule-The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies

Requires a High School Diploma or equivalent plus four
(4) years closely related technical experience, preferably in a
pharmaceutical or chemicals manufacturing environment. An Associates
Degree with a minimum of two (2) years closely related technical
experience, preferably in a pharmaceutical or chemicals manufacturing
environment; or a Bachelors degree, preferably in a science or
engineering field is preferred with 1 years of GMP exp.