Senior Validation Specialist

Pharma Validation Expert Needed About the Role: This is an exciting opportunity to work as a skilled Pharma Validation Engineer in Ireland. The successful candidate will be responsible for supporting various aspects of validation, including sterilization, cleaning, isolator, and controlled temperature units. Duties and Responsibilities: Design, author, review, approve, and execute qualification/validation documentation and cycle development studies in line with standard approval processes. 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 assigned areas 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. Represent the validation team at global technical forums and drive compliance of Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in day-to-day activities. Ensure 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. Work collaboratively to drive a safe and compliant culture in site. Requirements: Significant experience in a comparable role, with experience operating as an individual contributor adding value to the business in a GMP manufacturing setting. Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification. Knowledge of CTU equipment qualification, thermal mapping equipment, thermal mapping skills, exception/deviation management, and change control. Demonstratable experience of leading technical related projects, process monitoring systems, automation systems, operational intelligence & data systems, and regulatory/code requirements. Ability to analyze and interpret complex data, and link to equipment performance and out-of-specification findings as appropriate. Report, standards, policy writing skills, equipment and process validation, sterile fill-finish processes and equipment, proficiency in Microsoft Office, excellent communication, presentation, and interpersonal skills. Key Skills: 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

Creado: Jue, 01 de Ene de 1970