Cleanroom Validation Specialist
About the Role:
We are currently seeking a skilled Cleanroom Validation Specialist to join our team. This is an exciting opportunity for individuals who are passionate about ensuring the highest standards of quality and compliance in cleanroom environments.
Key Responsibilities:
* Design, author, review, approve, and execute qualification/validation documentation and cycle development studies in line with established standard approval processes.
* Develop and implement execution/development of change controls, ensuring seamless integration with existing systems.
* Investigate and resolve technical issues encountered during study execution, utilizing expert knowledge to drive resolution.
* Collaborate with production, maintenance, and quality representatives to ensure smooth execution of Cycle Development & Performance Qualification activities.
* Provide technical input into quality notifications by authoring, reviewing, and approving investigations, ensuring accuracy and timeliness.
* Conduct root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
* Drive continuous improvement through Lean Six Sigma methodologies, identifying areas for optimization and implementing effective solutions.
* Serve as validation representative for cross-functional projects, representing the validation team at global technical forums.
* Ensure compliance with Global Policies, Procedures, and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
* Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections, and proactively highlighting any issues around compliance.
Requirements:
* Experience in cleaning validation, including but not limited to CD & PQ of mobile vessels (CIP) and parts washers (COP), recipe development & optimisation, cleaning verification, cleanability, and recovery studies using TOC, ICP & swab methods, acceptable residual limit determination, worst-case soil matrices & strategy development.
* Considerable experience in a comparable role, with experience operating as an individual contributor adding value to the business in a GMP manufacturing setting, as well as relevant technical qualifications in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
* Demonstratable experience of leading technical-related projects, with knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment being beneficial and desirable.
* Sterile Fill-Finish processes and equipment experience is highly valued.
This is an excellent opportunity for candidates who are passionate about delivering excellence and driving continuous improvement. If you have the required skills and experience, we encourage you to apply.