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CSV engineers wanted!
We currently have many Computer System Validation projects available within our Pharmaceutical network.
Het bedrijf / The company
Within our Pharmaceutical client a global program was started to protect the company against cyber threats and natural disasters. This ERMD (Enterprise Resilience Modernization and Data Integrity) program has to ensure we are better protected and become more resilient when something happens in this area.
General requirements are defined for systems on Security, Modernization and Data Integrity. A system inventory shows that a large amount of automation systems need modifications to comply with the ERMD requirements.
A Taskforce identified several projects. 25% of the projects require equipment replacements or upgrades and 75% are automation driven. We will team-up approx. 10 project teams to execute the automation driven projects.
De functie / The role
For these project teams we are looking for Computer Systems Validation Engineers:
o Proactive and result oriented team player
o Familiar with process Automation
o > 5 year experience with Validation in Life Science / pharma
o Writing the Qualification Plan, Requirement Specifications, User Acceptance test protocol and Qualification Report will be part of your work
o You are responsible for compliance with the ERMD requirements and the validated state
o Interpretation of the compliance will be agreed with the Quality Officer
o Reporting progress deviations to the project leaders
o Writing qualification protocols
Het profiel / Your profile
Are you a CSV engineer experienced within the Pharmaceutical industry? You are ideally experienced in the following:
o Validation approach (QAP)
o Scope (SDLC)
o final Validated State
o Process Automation
o Writing the qualification plan
o Requirement Specifications
Het aanbod / The offer
Very competitive market offer
Tenslotte ..... / Finally ....
Feel free to get in touch at your nearest convenience to discuss some exciting projects.