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Process Equipment C&Q Engineer
This role will support the commissioning & qualification activities for a number of autoclaves and parts washers. The position is accountable for the timely completion of all C&Q milestones. Reporting to CQV Lead as part of a multi-discipline team responsible for Commissioning and Qualification activities.
• Manage, coordinate and guide Autoclaves and Parts Washer CQV execution based upon the validation plan.
• Ensure adherence to project schedule timelines.
• Serve as a subject-matter expert on Autoclaves and Parts Washer related activities.
• Author & review commissioning and qualification documents such as IOQ protocols, qualification validation protocols, summary reports and deviations.
• Owns the closure of any open issues such as SAT punches & deviations.
• Proactively recognises and highlights any compliance issues as they arise.
• Leads and maintains a safe working environment during CQV e.g. Work Permits, Safe Plans of Action, LOTO, etc.
• Trouble shoot Autoclaves and Parts Washer related issues.
• Supports system handover to Manufacturing.
• Demonstrates proficiency in communicating and collaborating with stakeholders and vendors
• Bachelor’s Degree in Engineering or relevant field
• Minimum of 3 years of C&Q experience in process equipment validation within the pharma or biotech industry
• Knowledge and experience with facility start-up projects (brown field or green field).
• Experience with complex projects and working in or around operating facilities.
• Ability to keep work pace and meet deadlines.
• Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
• Proven success working well in a team environment with flexibility to react to changing business needs.