Job Description
The successful candidates will support various aspects of Validation.
Key Responsibilities:
* Design, author, review, approve, and execute qualification/validation documentation and cycle development studies in line with the standard approval process.
* Design, author, review, approve, and execute execution/development of change controls.
* Resolve technical issues encountered during study execution.
* Engage with Production, Maintenance, and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
* Provide technical input into quality notifications 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.
* Support regulatory audits and submissions as required.
Requirements:
* Considerable experience in a comparable role, with experience operating as an individual contributor adding value to the business in a GMP manufacturing setting.
* Relevant technical qualifications in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
* 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.
* Evidence of continuous professional development is desirable.
* Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
* Ability to analyze 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-oriented manner.
Advantageous Knowledge and Experience:
* Equipment Periodic Validation.
* Equipment Validation Lifecycle.
* Project Management Skills/Qualification.
* Filter Validation & Container Closure Validation.
* Autoclave/SIP Sterilisation Validation.
* Dry Heat Sterilisation.
* Isolator Qualification.
* Vial and Syringe Processing Technologies.
* Temperature Mapping.
* Cleaning Validation.