Validation Engineer CSV

• Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities. Develops, implements and executes validation studies for cGMP-critical computerized systems to demonstrate compliance to cGMP-, User- and Regulatory requirements
• Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerized systems
• Responsible for the validation documentation through approval and implementation
• Performs validation of systems for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP’s and Sanofi Procedures
• Ensures that the Validated Status of computerized systems is in compliance with cGMP at all times
• Ensures projects are managed in conjunction with all required Sanofi and cGMP regulatory standards
• Keeps current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements. Provides technical assistance on current US FDA and EU validation requirements
• Provides input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate
• Investigates/troubleshoots validation issues

We are looking for a validation engineer who has project experience with validation of software packages and computerized systems has: 

• Strong communication skills
• The capability of working independently and learns fast 
• The ability to execute project to plan
• A good knowledge of Computer Systems Validation
• A full understanding of relevant quality and compliance regulations
• The capacities of troubleshooting validation issues
• Minimum a few years experience working in a pharmaceutical sector and GMP environment
• A very good knowledge of English and Dutch

Knowledge or experience with DCS systems (Emerson DeltaV) is strong advantage 

and availability

Enjoy transparent follow-up of your invoicing process

Manage all your administration in one app

• A permanent contract with a competitive salary, complemented by a monthly fixed expense allowance, a

USG Professionals connects the expertise and ambitions of highly educated professionals with the challenges of clients across six different fields: Engineering & Science, ICT, HR, Legal and Finance. We support our clients with temporary needs through project sourcing and with the permanent filling of open positions through recruitment & selection.

car and fuel card or a monthly gross bonus. Additional benefits include €8 meal vouchers, group and hospitalization insurance, a mobile phone subscription, and a year-end bonus.

This package is further enhanced with access to Benefits at Work, sport & culture vouchers, and eco vouchers.

You’ll also benefit from a varied and dynamic training offering, including both job-specific and cross-functional courses

Expect regular feedback and check-ins with your dedicated HR Business Partner

Get to know your fellow consultants during our networking events and team-building activities

Kickstart your career at USG Professionals with our two-day Bootcamp

Offer as a freelancer: 

• Streamline your freelance career with the USG EASY app
• Receive personalized project proposals based on your