▷ Urgent Bioprocessing Operator at VLE Therapeutics

Bioprocessing Operator at VLE Therapeutics
Bioprocessing Operator role at VLE Therapeutics supporting cGMP operational activities in the manufacturing facility, the MSAT area, and APC Biologics when required. The operator will be part of a team of operations professionals across a number of unit operations and execute batch operations per standard operating procedures in line with production schedules under limited supervision.

Position Summary
A key member in supporting the execution of cGMP operational activities in VLE Therapeutics’ manufacturing facility, the MSAT (Manufacturing Science and Technology) area and in APC Biologics when required. The Bioprocessing Operator will be part of a team of operations professionals across a number of unit operations throughout the process and is responsible for executing batch operations as per standard operating procedures in line with designated production schedules under limited supervision.

Responsibilities

Demonstrate high performance behaviours, work collaboratively within a cross-functional team, take independent initiative, focus on continuous improvement, and support a culture of excellence.

Operate equipment and run processes in a clean room environment in accordance with batch records, user manuals, design parameters, equipment qualification/validation protocols, and standard GMP operating procedures.

Execute operational activities for GMP production including equipment preparation, component cleaning, USP operations (Inoculum, cell culture) and DSP operations (purification, chromatography, Drug Substance Final Fill), filter integrity testing, and aseptic operations.

Adhere to safety, quality, and environmental compliance requirements and communicate/troubleshoot adverse events appropriately.

Understand and respond to adverse events, troubleshoot equipment issues, and react appropriately to non-standard events.

Monitor and collect data on critical parameters, notify supervision/technical support of potential upsets, and use data to identify issues or drive process improvements.

Perform process sampling and testing with analytical equipment (pH, conductivity, cell counting, environmental monitoring) and calibrate equipment as required.

Receive and verify all raw materials, set up equipment, prepare parts, and manage waste deactivation (e.g., biowaste system or autoclaves).

Log safety and quality events in appropriate systems and initiate process deviations as needed.

Complete required training on Individual Training Plans to conduct GMP manufacturing activities.

Support continuous improvement initiatives by identifying areas for improvement, recommending strategies, and implementing them once approved.

Collaborate with other departments and represent Manufacturing in cross-functional initiatives and meetings.

Maintain good housekeeping and sanitize classified areas as required.

Experience Qualifications

More than 3 years’ experience in cGMP Pharmaceutical Operations is essential.

More than 3 years’ experience in Drug Substance Biologics manufacturing is essential.

Vaccine manufacturing experience is preferable.

Advanced Therapeutics (Cell and Gene Therapy) manufacturing experience is a positive.

Aseptic operations experience is preferable.

Role may operate on rotating shifts and involve some non-scheduled call-in time to respond to plant emergencies and some scheduled call-in time for process operations.

Good working knowledge of MS Excel and Word.

Ability to work in a fast-paced, high-demand environment and balance multiple priorities.

Ability to work independently and as part of a team.

Education

Leaving Certificate or equivalent at a minimum.

Ideally a degree in a scientific discipline or equivalent experience.

How To Apply
Suitable applicants should submit a CV and Cover Letter. Closing date for applications is COB 29/8/2025.

Equal Employment Opportunity
VLE is committed to the principle of equal opportunity for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to gender, ethnicity, age, religious belief, disability, sexual orientation, gender identity and/or expression, marital status, or any other status protected by Irish law.

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