Senior Validation Engineer

Your Responsibilities

As a Senior Validation Engineer (all genders), you will be cooperating with R&D, service and support teams in order to provide computerized system validation (CSV) knowledge, products and services. You will have the opportunity to have a direct impact on our validation processes, products and services. You will also have the opportunity to support our market organizations in performing validations at customer sites.

• Create and update Validation Manuals (IQ - Installation Qualification and OQ – Operation Qualification) and procedures for Mettler-Toledo software products suitable for regulated market.
• Produce high-quality CSV documentation and procedures that comply with applicable standards in/with Schema ST4.
• Work with internal R&D teams to get an in-depth understanding of MT products and requirements.
• Collaborate with the Requirement Engineering team to provide input on regulated functionalities.
• Advise and guide R&D and Product Management on the implementation of regulatory requirements within software products.
• Research and gather information on the regulations which apply or may apply in regulated industry beside computerized systems to specify the most suitable requirements.
• Create and hold CSV training classes, create validation eLearnings.
• Support the validation of computerized systems.

What You Need to Succeed

Following requirements are necessary for this role:

• At least 4 years of experience in CSV in a regulated environment (GxP),
• Excellent understanding of GAMP5, CSV/CSA, FDA 21 CFR Part 11, EU Annex 11 and GxP practices,
• Experience in: designing CSV validation strategy or framework and creating CSV procedures and documentation, ideally in/with Schema ST4,
• Ability to create functional requirements from regulatory requirements,
• Proficiency in English communication and documentation,
• Strong project management and self-management skills; fully responsible for defining the scope, execution, and delivery of validation products in their final form,
• Very good communication skills - ability to grasp complex technical concepts and make them easily understandable for others (non-technical stakeholders),
• Proactive, forward-looking mindset; capable of driving transformation and change.

This will be your additional asset:

• Experience in validating cloud or SaaS solutions,
• Strong understanding of SDLC, DevOps and automated validation for SaaS products,
• Experience as field validation engineer.
• Experience with software validation in the pharmaceutical sector.
• Availability for travelling: occasionally

Our Offer to You

We offer:

• Flexible working hours (depending on the role), a hybrid work model, and a wide portfolio of training opportunities
• A 40-hour work week with at least 25 vacation days per year, plus 4 to 7 additional days off between