A leading bio-pharma organisation currently has a number of opportunities available for experienced validation engineers to join their team in their Carlow facility. These roles will be on initial 11-month contracts with great scope for extension/permanency.
Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
Provide technical input into quality notification by authoring/reviewing/approving investigations.
Execution of equipment commissioning and qualification programs.
Execution of equipment/qualification validation programs; including re-qualification and revalidation.
Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
Lead/Plan C&Q, validation activities as required
Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
3-5 Years experience working in a similar role/GMP environment
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
Report, standards, policy writing skills required
Equipment and process validation
Sterile filling processes and equipment
Proficiency in Microsoft Office and job-related computer applications required
Lean Six Sigma Methodology experience desired
For a confidential discussion and more information on the role, please contact Barry O'Brien