Senior Validation Engineer (Computerized System Validation) - - 21171

Our Opening and 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.

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

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 bank holidays
Free parking and direct access to public transport
Healthy lunches cooked onsite at our own METTLER TOLEDO restaurant, with special prices for employees
A range of additional attractive benefits, including employee discounts at select area businesses

You can expect challenging, interesting, and varied tasks in an innovative and international environment, with the opportunity to network globally and achieve your career goals.

Have we raised your interest? Then we look forward to receiving your complete application at our Job portal.

Please note that we do not accept any application documents via e-mail, only applications submitted on our job platform due to our data protection guidelines. Furthermore, we do currently not accept applications from recruitment agencies for this role.

If you have any question, please do not hesitate to contact our Talent Acquisition Team ta-ch@mt.com.

#MTCH

About Mettler Toledo

METTLER TOLEDO is a global leader in precision instruments and services. We are renowned for innovation and quality across laboratory, process analytics, industrial, product inspection, and retailing applications. Our sales and service network is one of the most extensive in the industry. Our products are sold in more than 140 countries, and we have a direct presence in approximately 40 countries. For more information, please visit www.mt.com.

Equal Opportunity Employment

We are an equal opportunity employer and value diversity at our company. We give consideration for employment without regard to race, color, religion, sex, age, national origin, disability, sexual orientation, gender identity, genetic information, or any other protected classification. You can find more details in our Equal Employment Opportunity Policy.

参考编号

21171

首选办公地点

Zürich

Nänikon-Greifensee

职位分类

全职

法人实体

Mettler-Toledo Technologies GmbH

Im Langacher 44 8606 Greifensee Schweiz

ta-ch@mt.com