Job Summary
The successful candidates will support several aspects of Validation. This role requires experienced, energetic and committed engineers in the following areas:
* Sterilisation - Autoclaves, SIP of vessels
* Cleaning - Parts Washer and CIP of vessels
* Isolator (Filling, Sterility & Material Transfer isolators) - HVAC, VHP, E-Beam and Depyrogenation systems
* Controlled Temperature Units (CTU) - Temperature/Humidity Mapping
* Filter Validation.
Role Functions:
* Design, author, review, approve, execute qualification/validation documentation and cycle development studies in line with the standard approval process.
* Design, author, review, approve, execute execution/development of change controls.
* Resolving technical issues encountered during study execution.
* Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
* Technical input into quality notification by authoring/reviewing/approving investigations.
* Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
* 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.
* 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, ensuring consideration of the impact on GMP and compliance and decisions made.
* Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance.
* Supporting regulatory audits and submissions as required.
* Work collaboratively to drive a safe and compliant culture in Carlow.
Experience:
* In order to excel in this role, you will more than likely have considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
* Knowledge of CTU equipment qualification.
* Knowledge of thermal mapping equipment.
* Thermal mapping skills.
* Exception / Deviation Management and Change Control.
* Demonstratable experience of leading technical related projects.
* Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.
* Evidence of continuous professional development is desirable.
* Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
* Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
* Report, standards, policy writing skills required.
* Equipment and process validation.
* Sterile Fill-Finish processes and equipment.
* Proficiency in Microsoft Office and job-related computer applications required.
* Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
The successful candidate will be required to work both independently and in a cross-functional team to accomplish validation project objectives. Works with moderate work direction and is skilled and knowledgeable to the position.