Biotechnology Validation Consultant

3 days ago

The Municipal District of Carlow, Ireland PSC Biotech Corporation Full time
Job Overview

PSC Biotech Corporation is seeking an experienced Validation Engineer to join our team. As a key member of our validation department, you will be responsible for ensuring compliance with Global Policies, Procedures, and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP) throughout day-to-day activities and job functions.

The ideal candidate will have significant experience in cleaning validation, including CD & PQ of mobile vessels and parts washers, recipe development & optimisation, cleaning verification, cleanability and recovery studies using TOC, ICP & swab methods, acceptable residual limit determination, worst case soil matrices & strategy development.

Responsibilities
  • Design, author, review, approve, and execute qualification/validation documentation and cycle development studies in accordance with established approval processes.
  • Develop and execute change controls, ensuring seamless integration into existing workflows.
  • Analyse and resolve technical issues encountered during study execution, applying expert knowledge to optimise outcomes.
  • Collaborate with production, maintenance, and quality representatives to ensure successful execution of Cycle Development & Performance Qualification activities.
  • Author and review technical inputs for quality notifications, ensuring accurate and comprehensive investigations.
  • Conduct root cause analysis of system failures and substandard performance, utilising standard tools and methods to resolve machine and system issues.
  • Promote continuous improvement through Lean Six Sigma methodologies, driving process enhancements and efficiencies.
  • Represent the validation team at global technical forums, fostering cross-functional collaboration and knowledge sharing.
  • Ensure compliance with Global Policies, Procedures, and Guidelines, regulatory requirements, and cGMP throughout day-to-day activities and job functions.
  • Accountable for compliance via documentation completion, risk assessments, corrective actions, participation in audits and inspections, and proactive issue highlighting.
  • Support regulatory audits and submissions as required, maintaining high standards of professionalism and attention to detail.
  • Foster a safe and compliant culture, collaborating with colleagues to drive excellence and success.

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