QA CSV Engineer New

Job Summary

This role will work in conjunction with the project team to provide resolution on questions as they arise during project design, construction, and qualification. They will support GMP design reviews, and CQV / CSV / Automation through all phases of the project up to and including Equipment PQ.

• Provide support to start up activities (Design, Build, CSV / CQV), and GMP operational readiness
• Partnership with CSV & CQV teams in delivering the GMP scope of work associated with the startup of sterile drug product operations, including QA approval of SOPs, deviations, CAPAs, change controls, risk assessments, validation documentation and documentation for manufacturing operations.
• Collaboration with functional areas for qualification to ensure knowledge transfer and robustness of control strategies.
• Drives and supports culture of continuous improvement initiatives and safe working practices.
• Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

• Bachelor/Masters in Engineering, or Science related discipline with a minimum of 5 years’ experience in Sterile Drug Product Manufacturing
• Understanding and experience of the principles of Annex 1 and how they translate into a contamination control strategy for sterile manufacture.
• Detailed knowledge of Sterile Drug Product would be a distinct advantage.
• Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix to meet accelerated timelines.
• Excellent communication and presentation skills are essential.
• Excellent time management and organizational skills along with a proven ability to multi-task

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