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Contract IT/OT GxP Engineer (GN*) (EN)
[1442]
Automatisierungstechnik, IT Sicherheit, cGMP
Role Scope ·Review existing inventory of IT/OT Systems (virtual and physical), and identify need for application / operating system updates, operating system patching and installation of cybersecurity protection applications ·Based upon availability, impact and risk, identify priority for remedial action on each system working with Process Owner / System Owner and IT Cyber Security team ·Review potential system changes with suppliers as needed as part of impact assessment ·Based upon agreed priority, work towards scheduling of changes on a system by system basis, combining with other activities where possible ·Generation of risk assessment / change control / testing documents for system changes ·Execute system upgrades as per schedule against approved documents Required Skills ·Minimum 3 years of relevant IT / Automation in a Pharmaceutical or biotech manufacturing setting ·Must have experience with upgrading / patching GxP IT and OT Systems ·Familiarity with cGMP regulations as they relate to IT and OT Systems ·Proven ability to work independently and manage multiple systems in parallel under tight timelines ·Strong technical writing skills and proficiency with risk assessment and change control ·Must be fluent in in business English (written / spoken). Spoken and written German to B1 level or above is beneficial for vendor communication ·Must have experience of working closely with vendors and suppliers ·Basic understanding of cyber security beneficial ·Ability to author procedures and processes beneficial ·Hands on mentality - ability to progress both documentation and physical activities on systems Framework ·Start: January 2026 ·Duration: currently 3 months ·FTE: 70 to 100% ·Working model: hybrid (potential for up to 40% remote work, upon agreement) ·Location: North Rhine-Westphalia *Wir von SSC setzen uns für ein vielfältiges und inklusives Arbeits- und Projekt-Umfeld ein. Wir tolerieren keinerlei Diskriminierung und sind stolz darauf, Chancengleichheit zu fördern.
- Review existing inventory of IT/OT Systems (virtual and physical), and identify need for application / operating system updates, operating system patching and installation of cybersecurity protection applications
- Based upon availability, impact and risk, identify priority for remedial action on each system working with Process Owner / System Owner and IT Cyber Security team
- Review potential system changes with suppliers as needed as part of impact assessment
- Based upon agreed priority, work towards scheduling of changes on a system by system basis, combining with other activities where possible
- Generation of risk assessment / change control / testing documents for system changes
- Execute system upgrades as per schedule against approved documents
- Minimum 3 years of relevant IT / Automation in a Pharmaceutical or biotech manufacturing setting
- Must have experience with upgrading / patching GxP IT and OT Systems
- Familiarity with cGMP regulations as they relate to IT and OT Systems
- Proven ability to work independently and manage multiple systems in parallel under tight timelines
- Strong technical writing skills and proficiency with risk assessment and change control
- Must be fluent in in business English (written / spoken). Spoken and written German to B1 level or above is beneficial for vendor communication
- Must have experience of working closely with vendors and suppliers
- Basic understanding of cyber security beneficial
- Ability to author procedures and processes beneficial
- Hands on mentality - ability to progress both documentation and physical activities on systems
- Start: January 2026
- Duration: currently 3 months
- FTE: 70 to 100%
- Working model: hybrid (potential for up to 40% remote work, upon agreement)
- Location: North Rhine-Westphalia
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