CQV Engineer
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| Job Type | Contractor |
| Area | Cork |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Telephone | +3539833013 |
| Job Ref | #1002494 |
| Job Views | 355 |
- Description
- 2494 - CQV Engineer
Team Horizon is seeking an experienced Senior CQV engineer with API experience of full life cycle activities incl. doc prep, change control and protocol execution.
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:
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 a 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 Constructio
Ensuring safe operation of the system prior to and during start-up functional testing and Qualification phases
Installation Verification execution
System Startup 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 Vendors 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 or a certificate/diploma in similar areas with appropriate industrial experience.
Minimum of 5 years’ experience of C&Q activities in a large project environment within the pharmaceutical or biotech industries.
Hands on expertise required in one or more of the following areas: API Facilities, Isolators
Experience with Regulatory and industry standards for GMP and GEP
Self-starter & good team player
Good oral & written communication skills