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CSV Engineer

  1. Denmark
Copenhagen
  1. Contract
Competitive
  1. CAPEX Projects
25-04-2024
32960
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CSV Engineer - Life Science - Copenhagen, Denmark - 12-Month Contract 

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CSV Engineer to join them on their new expansion project. Based in a charming Nordic location, this on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.


Responsibilities:
  • CSV Engineer responsible for generation and execution of protocols of various systems including Delta-V/MES/Infobatch and PI.
  • Liaise with CSV Leads and Automation PM in relation to CSV portion of Project Schedule. Coordinate and assist CSV Group for Project deliverables from Design through to PPQ Stage.
  • During Qualification clearly Identify and Develop with Automation the “Test Documentation” with the Automation and IT Team. Full identify full scope of all Computer System Validation Qualification efforts to be implemented for the Project, both GMP and Non-GMP Systems. 
  • Aligning with Automation, write Computer Systems Validation Protocols for the Automation & IT computer Systems, Support Automation Group in field execution and Final Report writing. Generate Project Change Controls for changes to Computer systems during Qualification. 
  • Support Design Qualification effort in relation to all CSV and Automation input for DQ and DQ Reporting.
  • Attend Risk Assessments sessions, representing Automation/CSV, including; Complexity/Customisation. Data Integrity Risk Assessments.
  • Liaising with Automation, interact with Software vendors, from FAT/SAT/IOQ.

Requirements:
  • Previous experience of working on and delivering a Verification / Leveraging approach Project for CSV work scope.
  • Minimum of 5 years’ experience implementing CSV scope and liaising with Automation on Large Scale Projects.
  • CSV of DeltaV systems would be advantageous but experience with PI/MES/Infobatch also a positive.
  • Experience with liaising with other departments and building PMs/leads. 
  • CSV experience including experience with design and construction projects for biopharmaceutical manufacturing facilities. 
  • Experience with complex projects and working in or around operating facilities.
  • Ability to keep work pace and meet deadlines. Good organisation and planning skills.
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
  • Proven success working well in a team environment with flexibility to react to changing business needs.
  • Strong communication skills. Problem solver with a focus on achievement of overall project goals.
  • Computer skills (Database, Access, EIDA, Spreadsheets, Word Processing, Visio, Microsoft Project).


If this role is of interest to you, please apply now! 

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