Manufacturing Bioprocess Technician

Job Description

Duties:

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 Purification that may include process monitoring, sampling, harvesting, purification, formulation 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).

Essential Technician:

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).

Trouble shoot 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.

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.

Job Matrix

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.

Judgment is required in resolving problems and making routine recommendations.

Ability to recognize deviation from accepted practices is required.

Supplementary Responsibilities:

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 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.

Qualifications

Degree in Life Sciences or engineering and 1 year related experience

Or Associate Degree and 3 year experience

Or High school and 5 years’ experience

Biotech certificate from approved program

Additional Information

Sneha Shrivastava

Sr Technical Recruiter

862 - 579 - 4236