Job Summary
The successful candidates will support several aspects of Validation. The roles available require experienced engineers in the following areas: Sterilisation, Cleaning, Isolator, Controlled Temperature Units and Filter Validation.
Key Responsibilities
* Design, author, review, approve and execute qualification/validation documentation and cycle development studies.
* Develop and implement change controls.
* Resolve technical issues during study execution.
* Engage with Production, Maintenance and Quality representatives during Cycle Development & Performance Qualification activities.
* Conduct root cause analysis of system failures using standard tools and methods.
* Sustain continuous improvement through Lean Six Sigma methodologies.
* Represent the validation team at global technical forums.
* Ensure compliance with Global Policies, Procedures and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
Requirements
* Considerable experience in a comparable role 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 and thermal mapping skills.
* Exception/Deviation Management and Change Control experience.
* Project leadership and process monitoring systems experience.
* Regulatory/code requirements knowledge.
* Data analysis and interpretation skills.
* Communication, presentation and interpersonal skills.
Desirable Skills
* Equipment Periodic Validation and Lifecycle experience.
* Filter Validation & Container Closure Validation experience.
* Autoclave/SIP Sterilisation Validation and Dry Heat Sterilisation experience.
* Isolator Qualification and Vial and Syringe Processing Technologies experience.
* Temperature Mapping and Cleaning Validation experience.