Validation Specialist Ireland

Há 5 dias


São Paulo, São Paulo, Brasil PSC Biotech Corporation Tempo inteiro
Job Title: Validation Specialist Ireland

We are seeking a highly skilled Validation Specialist to join our team at PSC Biotech Corporation. As a key member of our engineering team, you will be responsible for ensuring the quality and integrity of our products.

Key Responsibilities:
  • Design, author, review, and approve qualification and validation documentation and cycle development studies in line with our standard approval process.
  • Execute and develop change controls, resolving technical issues encountered during study execution.
  • Engage with production, maintenance, and quality representatives in the assigned area of operations during execution of cycle development and performance qualification activities.
  • 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.
  • 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.
Requirements:
  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
  • Proven track record in delivering excellence.
  • Knowledge of CTU equipment qualification, thermal mapping equipment, and 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.
  • 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.
What We Offer:
  • A challenging and rewarding role in a dynamic and growing company.
  • Opportunities for professional growth and development.
  • A collaborative and supportive work environment.
  • A competitive salary and benefits package.


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