Bioprocess Operator

  • Permanent
  • Dublin

Website Ref: TPM04228

Summary:
Our client, is a start up vaccine manufacturer who is seeking a Bioprocess Technician who will support the GMP manufacturing of clinical and commercial vaccines, next generation biologics & advanced therapeutics and aims to transform the time and cost associated to produce medicines for their clients.

Responsibilities:

  • 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.
  • Execution of operational activities for GMP production such as 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 compliance requirements (safety, quality & environmental) and ensure any adverse events are communicated/troubleshot appropriately.
    Be capable of understanding and responding appropriately to adverse events.
  • Ability to react appropriately to non-standard events.
  • Troubleshoot equipment issues, when necessary.
  • 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.
  • Process sampling and sample testing with analytical equipment, pH, conductivity, cell counting, environmental monitoring and routine calibration of same.
  • 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.
  • Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.

Qualifications & Experience:

  • Leaving Certificate or equivalent at a minimum.
  • Degree in a scientific discipline or equivalent experience preferred.
  • More than 5 years’ experience in cGMP Pharmaceutical Operations is essential.
  • More than 5 years’ experience in Drug Substance Biologics manufacturing is essential.
  • Vaccine manufacturing experience is preferable.
  • Advanced Therapeutics (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 have good working knowledge of MS Excel and Word.
  • Ability to work in an intense, fast-paced work environment.
  • Ability to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously.

To apply for this job email your details to orla.daly@tandempm.ie.