The ultimate purpose of technology teams in GxP environments is to serve the evolving needs of the business. We are a specialist provider of consultancy and implementation services for IT infrastructure and data architectures within life science manufacturing. Our role is to be a companion on the road for technology teams to be able to use as a tool at times when decisions need to be made.
We now have an amazing opportunity for an experienced CQV Engineer to join our client's growing team and work on site in Switzerland. This role is a full-time permanent role based on our client's site in Switzerland.
Your responsibilities will include, but won’t be limited to:
Manage all CQV activities associated with execution from the initiation/concept phase through construction to handover of multiple projects thus ensuring that all CQV activities are delivered to meet client expectations to the highest safety, environmental, quality, and operational & performance standards.
Direct support for the project managers who are delivering the projects.
Communicate and troubleshoot any issues arising from doc prep and doc execution phase of projects.
Assess and manage change controls in conjunction with the project managers including change control generation, review and approval.
Identify the appropriate Commissioning and Qualification strategy (IC/IQ and OC/OQ) to apply on specific project and define the list of activities required.
Communicate scope, cost and schedule impact to project managers and Client as required.
Assess and manage the requirements for CQV execution support from vendors, contractors, etc.
Implementation and co-ordination of new hire on-boarding and mentoring program.
Focusing on safety, schedule, and budget adherence while complying with good engineering practices, company policies, regulations, and codes.
The Requirements:
Have at least 3 years of experience in equipment commissioning, qualification, and validation (IQ, OQ, PQ).
2 – 3 years of previous experience in a data centre environment.
You must be competent with current FDA and EU regulations and best practices.
To find out more about what we do, visit our website here – https://oleson.io/
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