Bioprocess Technician

Job Title:

Bioprocess Technician

Job Description

The Bioprocess Technician performs a wide range of duties associated with aseptic biological production processes, including weighing, measuring, counting, calculations, sampling, and verifications in accordance with batch production records (BPR). This role operates within current good manufacturing practice (cGMP) standards, safety standards, and site procedures, supporting fermentation and related production activities on the manufacturing floor rather than in a laboratory setting.

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.

+ Complete all required training, including general company procedures, area-specific procedures, equipment operation, computer operation, safety, GMP, and other topics as assigned.

+ 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.

+ Apply 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.

Essential 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.

+ Capability to read, interpret, and follow batch production records (BPR), quality documents, and safety documentation.

+ 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.

+ Ability to multitask and think quickly in a dynamic production environment.

+ High School Diploma or equivalent.

+ Ability to complete required training on company procedures, area procedures, equipment operation, computer operation, safety, and GMP.

Additional

Skills & Qualifications

+ 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.

+ Experience working with fermentation systems, vessels, centrifuges, and other large-scale production systems.

+ Familiarity with cGMP standards and regulated manufacturing environments.

+

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.

+ Paid time off (PTO) and paid holidays are offered as part of the total…