Senior IT/OT Specialist (m/f/x) | Hamburg | Biotech/Pharma
In this position you will be responsible for implementing and maintaining central applications within an innovative Biotech company to support the departments in a GMP/non GMP regulated environment. The products consist of IT products for the lab environment, as well as custom IT solutions, developed internally or externally. As Senior IT/OT Specialist, you ensure the validation of documents for qualified system operation. With your strong IT know-how, you will support users and form the interface between different departments such as QA and central IT.
These tasks are waiting for you:
- Taking care of installation, operation, and maintenance of IT equipment at two production sites in collaboration with the central IT
- Identify and document requirements of internal customers and coordinate implementation of appropriate solutions
- Implementation and update of software applications with the focus on off-the-shelf applications that are not supported
- Guarantee data safety and data protection (backups, recovery) following GMP regulations such as CFR part 11 requirements
- Ensure qualification and computer system validation according to regulatory requirements
- Provide system and user administration of software applications
- Support in CAPA, deviations and change control regarding IT systems and software
- Create, implement, and assist in Audit trail review and annual reports
- Form the link between global and local IT as well as external service providers
- Perform troubleshooting and support if system failures occur
This completes your profile:
- Master's degree (MSc, diploma or equivalent) in IT, computer science or a related field
- 4+ years of industry experience with laboratory processes focusing on analytics
- Profound experience in IT application support
- Expertise in project management and demand management
- Experience with GMP, Data Integrity and inspections/audits
- Strong written and verbal communication skills in both English and German
About our client:
With their research in RNA technologies, they are driving innovation and expand their business while maintaining the start-up character. They are looking for open-minded, curious people, who are eager to join a fast-growing Biotech company to improve people's lives together.
