Job Opportunity
We are currently recruiting for an exciting opportunity within a Biopharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
This role is ideal for individuals with 2+ years experience working in Cleaning validation in a Fill finish environment.
Key Responsibilities
* Design and author qualification/validation documentation and cycle development studies in line with the standard approval process.
* Execute change controls, resolve technical issues encountered during study execution and engage with Production, Maintenance and Quality representatives.
* Author/review/approve investigations, perform root cause analysis of system failures and support continuous improvement through Lean Six Sigma methodologies.
* Serve as validation representative for cross functional projects and represent the validation team at global technical forums.
Benefits:
* Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
* Support regulatory audits and submissions as required.
Requirements
* Experience in cleaning validation including but not limited to CD & PQ of mobile vessels (CIP) and parts washers (COP).
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
* Demonstratable experience of leading technical related projects and knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial.
About Us:
A Biopharmaceutical organization based in Carlow offering opportunities for professional growth and development in a GMP manufacturing setting.