3077 Manufacturing BioProcess Technician
Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environments, and maintaining areas in high state of inspection preparedness.
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).
Responsible for being proficient in one functional area.
Understands and applies biological, chemical and mechanical principles and techniques.
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 of automation to perform production operations.
Provide support to Manufacturing to meet production demands.
Operate automated systems for equipment operation.
Assemble and prepare equipment for production.
Exhibit detail oriented documentation skills.
Communicate effectively and ability to work in a team environment.
Exhibit professional interpersonal skills.
Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
A good working knowledge of biopharm technology and processes.
Trained and skilled in all operational procedures of at least one manufacturing department.
Demonstrated ability to independently document and record information related to the process.
Occasionally makes routine decisions based on experience. Identifies and suggests solutions to common basic problems.
Recognizes non-routine problems, investigates and suggests potential solutions.
Operate fermenters, centrifuges, other harvest systems and protein purifications 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 batch feed fermenters; 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.
Knowledge, Skills and Abilities
Strong oral and written communication skills.
Familiarity of computer-based systems.
Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.
Degree in Life Sciences or Engineering and 1 year related experience, or Associate degree and 3 years experience, or High school and 5 years experience.
Biotech certificate from approved program.
Work Environment/Physical Demands/Safety Considerations Schedule could include a rotating (12 hour shift), one weekend day, evening or night hours, or full off-shift hours.
Expected to be on feet for 8 to 11 hours a day.
May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility Lifting up to 25lbs may be required.
Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment.
May work with hazardous materials and chemicals.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.
Fosters a positive safety culture in which no one gets hurt.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.