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Senior IT Specialist (m/f/x)

  • Location: Hamburg
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 11 months ago

  • Sector: Biotech
  • Contact: Liana Costanza
  • Contact Email:
  • Expiry Date: 04 February 2023
  • Job Ref: IT_2023_1_1672934279

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.