Bioprocess Associate

Desired Skills: Bioprocessing,Upstream processing,downstream processing,manufacturing,SOPs,Batch Records,GMP

We are looking for a BioProcess Associate to join our Drug Substance team at our state-of-the-art, fully integrated vaccine facility in Dundalk. As a Bioprocessing Associate, you will be a key member in our 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. 

Please click the link below to apply or alternatively send an up-to-date CV to howie.leahy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***