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Bioprocess Associate

Job description

Role Title: Bioprocess Associate
Role Type: 12 month contract
Location: Dundalk

We are looking for a BioProcess Associate – to join a Drug Substance team at a state-of-the-art, fully integrated vaccine facility in Dundalk Ireland. As a Bioprocessing Associate, you will be a key member in a fast-growing, dynamic startup-working with cutting-edge technology.

Please note This position will initially operate standard office hours Monday-Friday but will transition to a 12hr day shift pattern or 4 Cycle shift pattern to support routine site operations.


Bring energy, knowledge, innovation to carry out the following:
  • Manufacturing processes include DS Downstream Processing (DSP) and Upstream Processing (USP) and Buffer / Media preparation
  • Carry out all production operations in the assigned area as per the relevant SOPs and Manufacturing Batch Records .
  • Assist in maintaining a safety orientated Culture, cGMP compliant work environment at all times
  • Write, review and revision of area Standard Operating Procedures (SOPs), On the Job Training (OJT’s), Production Batch Records (PBRs), Logbooks, Training Competencies and Work Instructions
  • Training and mentoring of colleagues in SOPs, process execution and equipment operation.
  • Support Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training.
  • Assist with the investigation of and operations deviations through Quality System, engaging with all relevant personnel and functions as appropriate.
  • Lead and actively participate in shift handovers.
  • Liaise with Shift Lead regarding issues which may arise within the production area including highlighting of operational challenges.
  • Use Lean Tools as part of daily operations (Standard Work, 5S, TPM, Gemba, Method 1,) to optimize efficiency and drive the culture of Continuous Improvement (CI)
  • Support HAZOP and risk assessments as per requirements.
  • Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
  • Conducts all activities that are in accordance with Company policies & SOPs & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate.
  • Support the development, commissioning & qualification of a new vaccines drug substance manufacturing equipment and subsequent transition to commercial manufacturing.


What skills you will need:
In order to excel in this role, you will more than likely have:
  • Demonstrated experience in Bioprocessing, Upstream or Downstream.
  • Knowledge and experience of relevant cGMP, safety, and environmental regulations within the biopharmaceutical industry.
  • High level of adaptability working in a fast-paced environment and champion change.
  • Experience with recording information in real time using electronic or manual systems.?? 
  • Experience in executing operations while following SOPs, Batch Records and Manufacturing Controls Systems. 
  • Experience of working in Grade C, D and CNC environment is an advantage.? 
  • Excellent interpersonal skills, positive influence, team orientation, attention to detail, documentation skills, problem identification and problem-solving skills.? 
  • An ability to work independently, and as a member of a self - managed shift team in a dynamic, fast-paced environment that requires flexibility and initiative.