Website Asset Recruitment
This role will support the commissioning & qualification activities for a number of CTUs such as freezer, refrigerator, coldroom, ambient warehouse, etc. The position is accountable for the timely completion of all CTU-related commissioning and qualification milestones.
• Manage, coordinate and guide CTU CQV execution based upon the validation plan.
• Adhere to project schedule timelines.
• Serve as a subject-matter expert on CTU workstream, routes and circuit related activities.
• Author & review commissioning and qualification documents such as IOC/Q protocols, qualification validation protocols, summary reports risk assessments and deviations.
• Closure of any open issues such as SAT punches & deviations.
• Recognises and highlights any compliance issues as they arise.
• Lead and maintain a safe working environment during CQV (Work Permits, Safe Plans of Action, COHE, LOTO, etc.)
• Troubleshoot CTU-related issues.
• Identify and implement CTU related improvements where feasible.
• Supports system handover to Manufacturing/QC/Warehouse.
• Demonstrate proficient communicating and collaborating with stakeholders and vendors
• Participate in internal and external audits when required
• Temporary shift work may be required when necessary
• B.Eng or B.Sc in engineering or relevant science discipline is required.
• A minimum of 2-5 years’ experience for CTU CQV engineer role or 5+ years’ experience for senior CTU CQV engineer role working in a Biologics or similar GMP environment as part of an engineering or technical services function.
• Knowledge and experience with facility start-up projects (brown field or green field).
• Experienced in the execution of commissioning and qualification of CTUs.
• Possess in depth knowledge of hazards associated with CTUs
• Experience in troubleshooting and providing technical and engineering solutions for CTU-based operations and equipment in a biologics or similar processing environment.
• Good interpersonal skills with demonstrated ability to effectively work with cross functional area.
• Ability to manage and facilitate vendor or 3rd party testing companies
• Ability to present and successfully defend technical and scientific approaches (both written and verbally.)
• A qualification in project management is an advantage.