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C&Q Engineer – QC Instrument & Equipment
This role will Lead the C&Q activities for all QC instrument and equipment. This 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. This candidate should be an excellent communicator and will be required to work closely with a cross-functional team. Coordinate activities between Construction, Utilities, Automation, Operations.
• Liaise with CMT in relation to installation readiness and a schedule for QC equipment such as analytical instrument, QC autoclaves, BSC, Pass Box.
• Lead CQV review for Vendor Packages.
• Ensure Commissioning readiness to support QC instrument equipment testing.
• Lead PSSR field execution and guide equipment vendor in a safe and controlled manner.
• Develop wraparound qualification protocols/validation reports and execute all C&Q activities with equipment vendor.
• Assist the CQV PM in the planning and tracking of activities to ensure adherence to project schedule timelines.
• Facilitate QC instrument and equipment Turn over in conjunction with the site Operation Team (QC user team)
• Bachelor’s Degree in Engineering or relevant field
• Minimum of 3 years of C&Q experience in the pharma or biotech sector
• 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.