Manufacturing Associate I

High School Diploma /Associates Degree with exposure to science & math coursework
Familiar with biotechnology industry and biopharmaceutical manufacturing is preferred. Required 0-2 year related experience.
Must be able to work weekends, off-shifts, and overtime as required. Applicant must be willing and able to work reliably on a flexible schedule, Monday – Friday and some weekends, to meet the demands of the project.
Must be able to don gowning in the form of hospital scrub, gloves, safety glasses/goggles, coveralls and safety toe footwear with shoe covers multiple times per shift.
Handle and work with hazardous materials and chemical per standard operating procedures and OSHA guidelines.
Knowledge of cGMP regulations is preferred.
Good organizational and communication skills, both written and verbal, and the ability to prioritize competing tasks.
Excellent interpersonal skills with the ability to work well with others in a dynamic and highly collaborative environment. Ability to interact constructively with peers and support groups.
Ability to lift at least 20kg.

Primary areas of responsibility include raw material dispensing, assembly and movement of raw materials and equipment into staging or production areas, preparation of media and buffers, preparation and sterilization of parts and assemblies, stocking of materials and supplies.
Execute unit operations described in standard operating procedures, manufacturing batch records, and cGMP guidelines.
Perform bioprocess operations that include cell culture, filtration, and harvest.
Setup, maintenance, and use of cGMP equipment as directed by standard operating procedures and manufacturing batch records.
Familiarity of process automation and business quality systems and software.
Ensure work executed in compliance with company and regulatory quality policy and systems.

Familiar with biotechnology industry and biopharmaceutical manufacturing is preferred.
Knowledge of cGMP regulations is preferred.