Sr. Manufacturing Technician - 3rd Shift

Roche • Oceanside, CA

2d • Onsite

About The Position

Responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in a cGMP manufacturing environment and maintaining areas in a 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 applying expert knowledge of mechanical scientific principles, processes, and biopharmaceutical processing equipment. Additionally, you will: Provide coaching and training on best practices and compliance to SOPs. Prepare solutions for the production process. Participate in continuous operational improvement. Provide reports to management summarizing goal unit attainment. Work with coworkers and supervisors to effectively troubleshoot equipment and process issues. Understands the theory, concepts, and regulations behind biopharm technology and processes. A strong knowledge of at least one manufacturing department with an understanding of process impact in other areas. Anticipates potential problems and takes preventative action. Requires judgment to know when it is necessary to consult with supervisor and/or support groups. Understands how own actions impact others and uses this information in decision-making. 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.

Requirements

• Bachelor's Degree in Life Sciences or Engineering and 3 years experience, or Associate degree and 5 years experience, or High School and 7 years experience.
• Biotech certificate from an approved program.
• Excellent oral and written communication skills.
• Capable of writing detailed reports and summaries.
• Must possess a high level of automation and technical process knowledge as related to prep and process within area of responsibility.
• Familiarity with computer-based systems.
• Background in Cell Culture/Purification.
• 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.
• Exhibit detail-oriented documentation skills.

Nice To Haves

• Proficient in two or more functional areas.
• Expert knowledge of mechanical scientific principles, processes, and biopharmaceutical processing equipment.
• Understands the theory, concepts, and regulations behind biopharm technology and processes.
• Strong knowledge of at least one manufacturing department with an understanding of process impact in other areas.
• Anticipates potential problems and takes preventative action.
• Requires judgment to know when it is necessary to consult with supervisor and/or support groups.
• Understands how own actions impact others and uses this information in decision-making.

Responsibilities

• 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).
• Provide coaching and training on best practices and compliance to SOPs.
• Prepare solutions for the production process.
• Participate in continuous operational improvement.
• Provide reports to management summarizing goal unit attainment.
• Work with coworkers and supervisors to effectively troubleshoot equipment and process issues.
• Operate systems that clean and sterilize tanks and filtration systems.
• 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.

Benefits

• paid holiday time off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level