Ascend PM are hiring a CQV Engineer to join our clients team, a multinational biopharmaceutical company based in Dublin. This is a great Contract opportunity to join a growing team. Initially 12 Month Contract with view to extend. Contact or email CV to to find out more.
Overview:
Responsible for ownership of project deliverables, equipment, and documentation within a capital project. Acts as the Single-Use, Formulation, and Equipment Commissioning & Qualification (C&Q) Engineer, ensuring all C&Q activities are executed safely, on schedule, and in full compliance with GMP standards and quality requirements.
Key Responsibilities:
* 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).
Education / Experience:
* 3+ years experience in Engineering or Commissioning and Qualification Management
* Technical qualification at third level or equivalent in Engineering.
* Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects preferred
* Knowledge of safety, GMP and environmental regulatory requirements.
* Demonstrated strong Communication and Leadership skills.
* Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
* Strong understanding of a risk‐based approach to commissioning and qualification within the biotechnology industry
* Familiarity with paperless validation systems.