CQV Engineer - Isolators
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Telephone | +3539833013 |
| Job Ref | #1002165 |
| Job Views | 110 |
- Description
- C&Q Engineer – Team Horizon
Come join our client’s team as the C&Q Engineer for Isolators. This role is based in Dublin.
Why you should apply:
You will join an innovative team, working among a diverse group of visionaries, thinkers and doers, working on developing pioneering solutions that lead to shared success.
They put their people first and live their diversity and inclusion values embracing all
perspectives.
You enjoy working in a culture of learning and collaboration and making a positive impact.
What you will be doing:
Manage, coordinate and guide CQV execution based upon the site validation plan.
The C&Q Engineer shall be responsible for carrying out the following project related activities:
Preparation of documents associated with lifecycle of C&Q activities for an IV, FT, IQ, OQ.
Preparation and execution of FAT, Commissioning and SAT protocols
Preparation and execution of Qualification protocols (IQ and OQ)
Design Review (DR) and Design Qualification (DQ) protocol preparation, execution and follow-up
Field Walkdowns of systems as part of transfer of ownership of the system from Construction
Ensuring safe operation of the system prior to and during start-up functional testing and Qualification phases
Installation Verification execution
System Start-up activities
Functional Testing of systems
Change Management activities during project lifecycle
Summary Report writing
Organize and review daily tasks/verifications and track the progress of the activities assigned
Contractors and/or Vendor’s coordination
Interfacing with representatives on project team, Construction, Engineering, Automation, Quality and End Users during the different project phases.
What you need to apply:
A degree in science or engineering or equivalent.
You will need a good level of C&Q experience especially from large project environments within the pharmaceutical or biotech industries.
Hands on expertise in one or more of the following areas: API Facilities, Isolators would give you a great background for this position.
Experience with Regulatory and industry standards for GMP and GEP is very important
Being a self-starter, a good team player and have excellent oral & written communication skills will give you a great basis for this role.