Senior Validation Engineer (Computerized System Validation) (f/m/d)

As a Senior Validation Engineer (f/m/d), 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.

Your responsibilities: 

• 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:

• 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,

  • 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 traveling: occasionally. 

Our Offer to You:

• Contract of employment [umowa o pracę], we are looking for a long term cooperation,

• Annual reward 💰,

• IP rights,

• Hybrid work model🏠,  

• A diverse and inclusive workplace,

• Festive benefits paid in April and December,

• Medical care with basic dental package (Medicover), with possibility to extend to Damian Medical Center,

• Possibility to extend medical care to family members,

• Life insurance with possible extended scope,

• Sports card (Medicover),

• Language courses,

• Paid employee referral program,

• A vast training offer to support your development🚀,

• Fruity Wednesdays,

• Wellbeing activities, CSR, with space for your initiatives*,

• Discounts for meals and special offers at Platan Business Park,

• Possibility to work in an international environment with a multicultural team and have a big impact on employees engagement,

*We are focusing on entertainment and supporting your physical and mental health – check out our LinkedIn profile!

The recruitment process consists of the following steps:

• CV selection – we contact selected candidates

• Phone screening with a recruiter (approx. 15 min) 

• Initial interview with the Manager (videoconference)

• F2F meeting in Warsaw office combined with video conference with other stakeholders. To be confirmed if we will manage that with one meeting or will split for shorter slots. 

The information obligation arising from Article 18 [3ca] of the Labor Code is fulfilled before establishing the employment.