Job Type: Contract
Job ID: JO-2301-31604
Consultant: Karen McHugh
Are you a CQV Lead with 5+ years experience of C&Q activities in a large project environment within the pharmaceutical or biotech industries?
If you have the relevant experience, send your CV to firstname.lastname@example.org or call Karen on +353 17978720 for a confidential chat.
CQV Lead - Biotech Isolators - Tipperary
Our Client is one of Ireland's leading EPCm consultancies and a global player in the Semiconductor, Pharma and Biotech sectors.
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 Construction
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.
A degree in science or engineering or equivalent.
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
Minimum 12-month contract
Hourly rate €60 - € 70
Karen McHugh is the consultant managing this position.
If you are a CQV Lead interested in roles based in Tipperary you can contact Karen by e-mail at email@example.com or phone +35317978720 for a confidential chat.
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