The BioProcess Manufacturing Technician is responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintaining areas in high state of inspection preparedness. The incumbent in this role:
Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer.
Performs media/buffer solution preparation operations.
Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).
Operate systems that clean and sterilize tanks and filtration systems.
Prepare solutions for the production process.
Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
Troubleshoot equipment and process problems.
Comply with safety requirements, cGMP, SOP and manufacturing documentation.
Use automation to perform production operations.
Operate automated systems for equipment operation.
Assemble and prepare equipment for production.
Partner with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
Foster a positive safety culture.
Recognize problems, investigate and suggest potential solutions.
Identify deviation from accepted practices
Operate bioreactors, centrifuges, other harvest systems and protein purification units.
Operate and clean fixed tank and filtration systems
Operate large scale column chromatography systems.
Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L bioreactors; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
Perform solution preparation activities (media and buffer make-up).
Clean, assemble, and sterilize equipment using glass washers and autoclaves.
Perform automated CIP and SIP of fixed equipment.
The level of the position will depend on the qualifications of the selected candidate. There are multiple positions available across both Day and Night shifts.
High school diploma with college-level course work in biological science, physical sciences or at least 2 years of relevant experience; BA/BS in life/physical sciences or related discipline preferred.
Strong knowledge of at least one manufacturing department with an understanding of process impact of other areas.
Understanding of the theory, concepts, and regulations behind biopharma technology and processes.
Good problem solving, mechanical aptitude, interpersonal communication and team skills.
Self-starter with strong focus on quality, details and results.
Effective time management and organizational skills.
Possess proficiency in business applications including inventory control systems.
Must be able to be flexible in work assignments, work weekends, off shifts and overtime as required.