Bioprocess Technician

Responsibilities

• Perform aseptic production activities such as weighing, measuring, counting, calculations, sampling, and verification in alignment with batch production records (BPR) and cGMP requirements.
• Support biological production processes involving fermentation, centrifugation, concentration units, and handling of biological organisms.
• Understand and operate production equipment, ensuring all equipment, instruments, and production materials are properly released and available for use.
• Look up and perform accurate transactions within the electronic inventory management system to maintain proper material and equipment tracking.
• Oversee production processes, including cleaning activities, environmental monitoring, and personnel practices to maintain compliance with written procedures.
• Conduct in-process batch quality checks according to documented procedures and quality standards.
• Follow all safety rules and site safety practices, consistently wear appropriate safety equipment, and maintain a strong safety mindset.
• Use basic computer skills to create and update standard operating procedures (SOPs) and to write deviation reports when issues or nonconformances arise.
• Generate and share new ideas to improve workplace practices and production processes, contributing to continuous improvement.
• Read and interpret batch records, quality documentation, and safety documentation to ensure accurate execution of processes and compliance with standards.
• Perform aseptic technique and sterile processing principles to maintain product integrity and prevent contamination during production.
• Support bioprocessing and manufacturing activities by working with fermentation systems, vessels, centrifuges, and other large-scale production systems.
• Perform instrumentation and mechanical tasks related to equipment operation, troubleshooting, and basic maintenance on the production floor.
• Maintain accurate documentation of production activities, quality checks, deviations, and process changes in accordance with SOPs and GMP requirements.
• Demonstrate a big-picture mindset, thinking on your feet and multitasking effectively to manage multiple steps in production processes.

Requirements

• Ability to perform aseptic techniques and sterile processing in a production environment.
• Basic knowledge of fermentation processes, centrifuges, concentration units, and biological organisms.
• Ability to understand and operate production equipment and instruments used in large-scale bioprocessing.
• Basic computer skills for creating and updating standard operating procedures (SOPs), writing deviation reports, and completing electronic training modules.
• Ability to perform accurate transactions within an electronic inventory management system.
• Strong adherence to safety rules, use of appropriate safety equipment, and consistent application of safe work practices.
• Attention to detail in performing measurements, calculations, sampling, and in-process quality checks.
• Able to multitask and think quickly in a dynamic production environment.

Qualifications

• High School Diploma or equivalent.
• Associate of Applied Science (AAS) or Bachelor’s degree in Biotechnology or a related scientific field is preferred.
• Previous experience in a manufacturing or production setting is preferred.
• Familiarity with cGMP standards and regulated manufacturing environments.
• Experience working with fermentation systems, vessels, centrifuges, and other large-scale production systems.
• Experience with bioprocessing and biological manufacturing operations.
• Ability to contribute ideas for process improvements and workplace efficiency.
• Strong documentation skills for maintaining accurate records and writing deviation reports.
• Capability to perform basic instrumentation and mechanical work on production equipment.
• Understanding of quality principles in manufacturing and in-process batch quality checks.

Skills

• Ability to perform aseptic techniques and sterile processing in a production environment.
• Basic knowledge of fermentation processes, centrifuges, concentration units, and biological organisms.
• Ability to understand and operate production equipment and instruments used in large-scale bioprocessing.
• Basic computer skills for creating and updating standard operating procedures (SOPs), writing deviation reports, and completing electronic training modules.
• Ability to perform accurate transactions within an electronic inventory management system.
• Strong adherence to safety rules, use of appropriate safety equipment, and consistent application of safe work practices.
• Attention to detail in performing measurements, calculations, sampling, and in-process quality checks.
• Able to multitask and think quickly in a dynamic production environment.

Benefits

• Paid time off (PTO) and paid holidays are offered as part of the total rewards package.
• Medical, dental & vision coverage.
• Critical Illness, Accident, and Hospital coverage.
• Life Insurance (Voluntary Life & AD&D for the employee and dependents).
• Short and long-term disability coverage.
• Health Spending Account (HSA).
• Transportation benefits.
• Employee Assistance Program.