Bioprocess Associate

Desired Skills: GMP,Downstream,Upstream

PE Global is currently recruiting a Bioprocess Associate for a leading multi-national Biotech client based in Dundalk.

This is an initial 11-month contract position, that will start initially on days before moving to an extended day shift Rota.

ROLE:

• 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 always
• 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.

REQUIREMENTS:

• 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.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Seán on +353 86 3514962 or alternatively send an up-to-date CV to sean.molloy@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***