On behalf of their Client, Kenny-Whelan are hiring a Process Cleaning Validation Representative for a Global Life Sciences Company in Cork.
Profile of the role:
The Small Molecule Process Cleaning Validation Representative will assist the Small Molecule Cleaning Process Team (SMTPT) in planning, executing and the continuous improvement of Cleaning across the Small Molecule business.
Main duties and responsibilities:
Responsible for the delivery of the Production Cleaning including but not limited to:
o Lead the Morning and Evening Handover meetings during Cleaning
o Deliver the execution of Cleaning on schedule
o Responsible to meet business plan for Cleaning cycle times, identify bottlenecks and own resolutions.
o Deliver all the documentation e.g. Tickets, Viz Boards, etc. associated with Cleaning
o Track progress and downtime during Cleaning collecting data that will improve future Clean-ups
o Prepare Swab Kits and Cleaning Wipes
o Ensure all equipment and consumables are readily available well in advance of Clean-ups
o Participate in or lead After Action Reviews for Clean-ups
o Drive medium to long-term improvements in the Cleaning program based on external benchmarking / industry trends.
o Support the SMTPT in the development and ongoing execution of a Cleaning training programme / education for the Process and Operations Teams.
o Generate Cleaning Campaign Summaries and present to Flow
o Improve efficiency on Cleaning processes and identify projects for improvements
o Support Operations Team Leader in planning and scheduling daily work.
o Support the Maintenance Planner by scheduling PMs and Work Orders into the Cleaning/Turnaround Schedule
o Equipment and process knowledge to be able to support trouble shooting
o Small Molecule Cleaning Process Team member attending weekly PT meetings
o Creating non-routine work instructions (attachments to Tickets, non-routine work instructions, etc.) with input from the Process Team.
o Organising/ completing non-routine sampling during Cleaning.
o Support the execution of Lean initiatives in the building associated with Cleaning
Education and Requirements:
BSc in either Engineering (Chemical, Validation or relevant) or Science
Candidates with Diploma in Chemical Engineering will also be considered
At least 2 years similar experience to what is outlined above supporting a Pharmaceutical / Biotech` manufacturing site.
Additional Skills desired:
o Technical knowledge of processing equipment and cleaning regimes (chemical, re-circulated washing, etc.)
o Knowledge of Small Molecule manufacturing processes and understanding of production schedules
o Interested in standardisation of Cleaning business systems across Small Molecule and benchmarking with internal and external colleagues.
o Continuous Improvement mindset i.e. always looking for a better, more efficient way
Please note that as this is a Contract role you need to be eligible to work in Ireland, hold a Stamp 1G or Stamp 4 Visa
All applications will be treated with the strictest confidence
Kenny-Whelan Contact:
For further information please contact Carmel Synnott on 087 7422268 or send your updated CV to [email protected]