GMP Bioprocess Operator - Vaccines & Biologics

Uniting Holding; Dublin; On-site; EUR 60,000 - 90,000; Full time

Job summary

VLE Therapeutics is building a new Irish-owned biomanufacturing facility focused on vaccines, advanced therapeutics and biologics. The Bioprocessing Operator will contribute to GMP production in a fast-paced, cross-functional team environment.

You will operate clean room equipment, perform inoculum and cell culture work, and support purification and fill/finish processes while adhering to strict quality and safety standards. English fluency and strong MS Office skills are required.

Qualifications

• More than 5 years of experience in cGMP Pharmaceutical Operations is essential.
• More than 3 years of experience in Drug Substance Biologics manufacturing is essential.
• Aseptic operations experience is preferable.

Responsibilities

• Operate equipment and run processes in a clean room environment according to batch records, manuals, parameters and GMP procedures.
• Perform equipment preparation, cleaning, inoculum handling, cell culture and DSP operations (purification, chromatography, Drug Substance Final Fill).
• Conduct filter integrity testing and aseptic operations.
• Adhere to safety, quality and environmental requirements and report adverse events.
• Troubleshoot equipment issues and respond to non-standard events as needed.
• Monitor and collect data on critical parameters and communicate up to supervision/technical support.
• Perform sampling and testing with analytical equipment and environmental monitoring.

Skills

Cross-functional collaboration

Independent initiative

Leadership

Education

Leaving Certificate

Science degree (L7/L8)

Tools

MS Excel

MS Word

Job description

VLE Therapeutics is building a new Irish-owned biomanufacturing facility focused on vaccines, advanced therapeutics and biologics. The Bioprocessing Operator will contribute to GMP production in a fast-paced, cross-functional team environment.

You will operate clean room equipment, perform inoculum and cell culture work, and support purification and fill/finish processes while adhering to strict quality and safety standards. English fluency and strong MS Office skills are required.