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Digital Platform Senior Validation Engineer f/m
A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role :
You will be responsible for the guidance and direction of validation projects covering all the Life Science digital products, applications, computerized systems.
You will provide expert guidance on all aspects of computerized systems validation and will need to travel to directly assist individuals/site requiring specific support for a limited time during regulatory inspections and/or large projects.
You will review and become an expert in the regulatory guidelines as well as being current on potential changes which may impact the validation requirements.
You will also provide expert guidance during regulatory audits and will provide project management support for projects which don't have site specific support systems in place.
The main responsibilities include (but are not limited to) :
- Computerized systems / digital products/ Control Systems/ Software / OT (Operational Technology - industrial software) / Cloud based solutions, IT Validation (IQ,OQ,PQ, Test Scripts, Protocols, Infrastructure qualification protocols, back-up restoration testing, audit trail testing) / quality assurance, Validation Master Plan meeting GAMP, QMS (Quality Management Systems), P/D-DP (Product/Digital Development Process) and regulatory requirements based on the systems need/scope of target market and internal/external use in GMP area. Lead the team validation engineers and will be single point of contact for the program status.
- Perform 21 CFR Part 11, Annex 11, Risk Assessments, Functional risk assessments, Data Integrity Assessments, FMEA to ensure the requirements, controls are captured prior to development and ensure tested system met those requirements. Including ability to review URS, Functional Spec, Design Spec, Test Scripts, User Manual for computerized systems, digital products, software applications (for both COTS and new products/solutions for target markets)
- Operational Change Control, including customer complaints handling, periodic review and re-validation of multiple digital products and software applications. Actively participating as auditee presenting/explaining validation and qualification documents to the regulatory, customer auditors and internal / external auditors.
Position based in Molsheim (67).
Please submit your application in english (resume + cover letter).
Who you are :
- Bachelor’s degree in chemical, computer science, bio medical, engineering or another life science discipline
- 7+ years of relevant experience in validation, handling of multiple projects and quality assurance
- Good written and verbal skills in English
- Excellent computer skills, i.e., Project Planning, Word, Excel, PowerPoint, SharePoint
- Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes
- Travel Requirements: Global travel required based on the need of project and business
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com