Head of OT - Computer System Validation (all genders)

A career at our company is an ongoing journey of discovery: our 60,300 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:

As part of the AmpTec team in Hamburg, you will be responsible for setting up, maintaining and supporting central applications to support the analytical departments at AmpTec in the GMP and non GMP area. The products out of this group are off the shelf IT products for the lab environment, as well as custom IT solutions, developed internally or externally. You will record the requirements of internal customers, document these requirements and coordinate the implementation in cooperation with partners. This includes the responsibility for and maintenance of validation documents for qualified system operation as well. You will support users with IT know-how and form the interface between laboratory staff, central IT, device manufacturers and QA. This position is located in Hamburg, Germany and valid only for German residence.

Responsible for

• Design, order, installation, operation and maintenance of IT equipment at two production sites/labs of AmpTec for Hamburg in collaboration with the central IT.
• Installation and update of software applications. Focus on off-the-shelf applications that are not supported by global IT.
• Data safety and data protection (backups, recovery) following GMP regulations like CFR part 11 requirements
• Setup, execute and maintenance of qualification and validation for GMP compliant system operation (CFR part 11 compliant documentation)
• System and user administration of software applications
• Support in deviations, change control, CAPA regarding IT systems and software
• Design, implement and support Audit trail review and annual reports
• Link between our global IT and AmpTec entity
• Link between AmpTec and external service provider
• Troubleshooting and support in case of system failures

Your qualifications:

• Master degree (MSc, diploma or equivalent) in information engineering or computer science
• 5+ years of industry experience laboratory processes with focus on analytics
• Experience in IT application support
• Competence in requirements analysis and project management
• GMP understanding, Data Integrity and audits/ inspections experience
• Fluency in German and English, good written and verbal communication skills

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html