Bioprocess Operator

Position Summary

A key member in supporting the execution of cGMP operational activities in a manufacturing facility.

Principal Responsibilities

• Demonstrate high performance behaviours, ability to work collaboratively within a cross functional team, ability to show independent initiative, to have a focus on continuous improvement and have a strong belief in supporting the right culture in the business.
• Operate equipment and run processes in a clean room environment, in accordance with batch record, user manuals, design parameters, equipment qualification protocols and validation protocols and current standard GMP operating procedures
• Monitoring and collecting data (including input to an electronic system) on critical parameters to anticipate potential upsets and notifying supervision/technical support of same. Data is used to identify issues and/or make process improvements.
• Receiving and verification of all raw materials. Equipment set-up. Parts preparation. Deactivation of waste i.e., Biowaste system or autoclaves
• Logging safety and quality events in the appropriate systems, including initiating process deviations
• Completion of all relevant training on associated Individual Training Plans to complete manufacturing activities in a GMP manner.
• Maintain good housekeeping and clean and sanitize classified areas as required.

Experience & Qualifications

• Experience in cGMP Pharmaceutical Operations is essential.
• Experience in Drug Substance Biologics manufacturing.
• Vaccine manufacturing experience is preferable.
• Cell & Gene Therapy manufacturing experience is a positive.
• Aseptic operations experience is preferable.
• The role may operate on rotating shift position and may also involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to attend process operations.
• Must be able to read, write and converse in English.
• Must have good working knowledge of MS Excel and Word
• Ability to work in an intense, fast-paced work environment.

Education

• Leaving Certificate or equivalent at a minimum. Degree in a scientific discipline or equivalent experience preferred.