Skip to main content

CSV Engineer

  1. Denmark
Copenhagen
  1. Contract
Competitive
  1. CAPEX Projects
32960

This vacancy has now expired

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! 

 #LI-ML1
Save as a job alert
List #1

Similar Jobs

Production Operator

Salary

Competitive

Location

County Dublin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

Dublin

Description

Production Operator - Pharma - Dublin - 11 months + possible extension  This is a fantastic opportunity to be part of a fast-paced, €700 million project; with lots of opportunities to work with

Reference

36065

Expiry Date

01/01/0001

Dawn Hosier

Author

Dawn Hosier
Dawn Hosier

Author

Dawn Hosier
Read more
Senior Electrical Project Manager

Salary

Competitive

Location

Groningen

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Netherlands

North

Description

Senior Electrical Project Manager - Northern Netherlands - 12-Month Contract Are you a Senior Electrical Project Manager looking for your next contract role? We have a fantastic opportunity

Reference

35719

Expiry Date

01/01/0001

Gary Bartholomew Read more
Senior MEP Project Manager

Salary

Competitive

Location

Groningen

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Netherlands

North

Description

Senior MEP Project Manager - Northern Netherlands - 12-Month Contract Are you a Senior MEP Project Manager looking for your next contract role? We have a fantastic opportunity for you to join

Reference

35720

Expiry Date

01/01/0001

Gary Bartholomew Read more

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.