CQV Engineer

Team Horizon is seeking a CQV Engineer for a leading pharmaceutical company in South Dublin.

Owns projects, equipment, responsible for document drafting and protocol execution.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people's lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Single Use / Formulation / Equipment Commissioning and Qualification (C&Q) engineer for a capital project. Ensure the C&Q activities associated with the capital project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.
• Commissioning & Qualification of Single Use Systems / Formulation Equipment / Process equipment.
• Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report.
• Provide technical assistance during investigations and system design.
• Coordinates and Supervises all C&Q activities on their systems.
• Ensures the C&Q schedule is maintained.
• Manages Daily C&Q coordination meetings.
• Responsible for Tracking and Reporting of C&Q status and risks/issues.
• Ensures Startup of equipment/utilities is completed in a safe and coordinated manner.
• Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
• Any other duties as assigned.

What you need to apply:

• Commissioning & Qualification of Single Use Systems / Formulation Equipment / Process equipment.
• Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report
• Provide technical assistance during investigations and system design.
• Coordinates and Supervises all C&Q activities on their systems.
• Ensures the C&Q schedule is maintained.
• Manages Daily C&Q coordination meetings.
• Responsible for Tracking and Reporting of C&Q status and risks/issues.
• Ensures Startup of equipment/utilities is completed in a safe and coordinated manner.
• Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).