Kelly Services are currently recruiting a Senior Commissioning and Validation Lead for our Global Pharmaceutical client in South Co. Dublin.
This is a 1 year contract initially with excellent opportunity for permanency.
Excellent rate available.
As the Commissioning and Qualification (C&Q) lead for a large scale Fill Finish Project, you will Lead a team of C&Q engineers to ensure the C&Q activities are completed safely, as per schedule and in compliance with GMP and Quality Requirements.
* Coordinates and Supervises all C&Q activities
* Approves C&Q planning documents detailing overall strategy for the project.
* Develops and approves the master list of C&Q test documents and activities.
* Reviews and Approves all C&Q summary reports.
* Ensures the C&Q schedule is developed and maintained.
* Ensures all C&Q Engineers who perform C&Q activities have relevant training assigned.
* Pre-Approval and Post approval of C&Q test documents.
* Manages Daily C&Q coordination meetings.
* Responsible for Overall 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:
* 4-5+ 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
* Experience of sterile / biotech equipment within the pharmaceutical industry is 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.
Please apply today or contact Niall on 086-4113572 for more information.
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.