With highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness Manufacturing, Manufacturing gt General Manufacturing Responsible for being proficient in two or more functional areas ,…
Full Description :
Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain 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 two or more functional areas and applies expert knowledge of mechanical, scientific principles, processes and biopharmaceutical processing equipment.
Represent the department on cross-functional project teams.
Coordinate with technology, Facilities, Engineering and EHS to optimize equipment performance
Process monitoring and trending across all shifts.
Expert in business support systems (BPCS, POMS, CIM21) and facility systems (water, CIP).
Collect, interpret and communicate process metrics; utilize metrics to recommend improvements.
Through knowledge of biopharm technology, processes and the underlying scientific concepts.
Must demonstrate a comprehensive understanding of both general and specific aspects of multiple manufacturing departments.
Troubleshoot and investigates complex problems, works with others to implement solutions.
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 equipment and process issues.
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.
Operate bioreactors, centrifuges, other harvest systems and protein purifications units.
Operate and clean fixed tank and filtration systems.
Operate large scale column chromatography systems.
Operate large scale UF/DF and Freeze Thaw Systems.
Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20-L batch feed 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.
Education and Experience
Degree in Life Sciences or Engineering and 5 years experience, or Associate degree and 7 years experience, or High School and 9 years experience.
Biotech certificate from approved program.
Knowledge, Skills and Abilities
Excellent oral and written communication skills demonstrated by communicating with other functions and management regarding resolving investigations and theory.
Ability to lead department and/or cross functional meetings or projects.
Work Environment/Physical Demands/Safety Considerations:
Ability to work a flexible shift structure
Expected to be on feet for 10 to 12 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 a clean room environment.
May work with hazardous materials and chemicals.
is an equal opportunity employer.
Manufacturing, Manufacturing > General Manufacturing