IT Solution Manager

Epico is looking for IT Solution Manager
Job Description
We are seeking an experienced IT Solution Manager to support the Compliance project team supporting the filling factory at site Gentofte. The IT Solution Manager will lead IT-specific compliance and assurance activities required in various projects, with primary responsibility for completion and sign-off of IT deliverables including the IT Risk Assessment (ITRA), ITPSE, Disaster Recovery Plan, Design Qualification (DQ) review and signature, and Validation Plan (VPL) review and signature. The role requires IT Solution Manager training certification from the pharma industry.
Key Responsibilities
* Lead scoping and creation of the IT Risk Assessment (ITRA)
* Collaborate with project subject matter experts (SMEs) to gather inputs and define ITRA scope
* Identify IT assets, interfaces, risk scenarios and risk mitigation measures
* Produce and maintain the ITRA document in line with standards and timelines
* Update and finalize ITRA to enable scheduling of FAT and SAT
* Complete the ITRA, DRP, ITPSE etc. within project deadlines
* Drive consultations and workshops with stakeholders to ensure timely completion
* Ensure the ITRA is traceable, auditable, and aligned with validation and quality requirements
* Review and sign-off IT-related validation documents
* Review Design Qualification (DQ) for IT impacts and provide formal IT Solution Manager signature
* Review and sign the Validation Plan (VPL) from an IT perspective
* Ensure all IT-related requirements, risk controls and test strategies are reflected in DQ and VPL
* Stakeholder engagement and coordination
* Work closely with project SMEs (controls, automation, facilities, quality, suppliers) to ensure IT requirements are captured and addressed
* Liaise with suppliers and vendors to clarify IT interfaces and responsibilities
* Provide input to scheduling for FAT and SAT based on IT readiness
* Compliance, documentation and traceability
* Ensure all IT deliverables meet policies, validation and GMP requirements
* Maintain clear records of reviews, decisions and signatures for audit readiness
Required Skill/Experience/Education And Qualifications
* IT Solution Manager training certification from the pharma industry
* Proven experience as IT Solution Manager, IT owner or equivalent role supporting validation activities in regulated environments (pharmaceutical, biotech, food)
* Experience preparing or reviewing ITRA / IT risk assessments and validation documentation (DQ, VPL, IQ/OQ/PQ experience desirable)
* Strong understanding of IT architecture for industrial/automation environments (networking, PLC/SCADA interfaces, servers, endpoints, backup, cybersecurity)
* Familiarity with FAT and SAT processes and requirements
* Excellent stakeholder management, communication and facilitation skills
* Attention to detail and strong documentation skills
Desired
* Knowledge of GxP, GDPR and cybersecurity best practices for industrial systems
Jobbdetaljer
* Startdatum
30 november 2026
* Varighet
7 mån. (30 november 2026 - 29 juni 2027)
* Plats
Gentofte, Denmark
* Deadline
12 november 2026 kl. 11:00
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