IT/OT Program Management & CSV Project Coordination GMP Environment

Project overview

we have the following project to assign:

IT/OT Program Management & CSV Project Coordination GMP Pharma

Responsibilities

• Support of ongoing IT and OT infrastructure initiatives in a regulated project environment
• Participation in CSV project coordination for manufacturing systems, laboratory systems, and connected production equipment
• Creation and maintenance of integrated project plans, including milestones and dependencies for project support
• Coordination of collaboration and communication between global IT, Operations, Engineering, Quality, as well as local and global project stakeholders and external partners
• Optimization of project governance, reporting, and risk management processes within the scope of project participation
• Tracking of risks, decisions, open points, and cross-project dependencies
• Preparation of steering committee documents and status reports to support project communication
• Coordination with external service providers for automation and validation to support the project
• Participation in inspection preparation for systems in regulated environments
• Support of knowledge transfer and transformation activities within ongoing projects

Requirements

Framework data:

Interested? Then we look forward to your reply directly in the portal with your profile in WORD format including detailed project descriptions for the MUST criteria, a PDF with all certificates and three relevant project references. Please state your hourly rate, availability, desired workload, date of birth, and nationality. We will arrange a meeting with our business client and will contact you promptly with our contact details, which Freelancermap hides here.

Thank you very much.

Sincerely

Dirk Fasold

Dipl.-Wirtsch.-Ing.

Dirk Fasold Business Partner & Consultant

*@*.solutions

*

• MUST: Core competence in IT/OT project management or comparable with several years of expertise in regulated environments
• MUST: Project expertise in the pharmaceutical, biotechnology, or manufacturing environment
• MUST: Very good knowledge of stakeholder structures and project governance
• MUST: Expertise in coordinating external service providers and international project stakeholders
• MUST: Project experience with manufacturing systems, infrastructure projects, or connected production systems
• MUST: Expertise in Computer System Validation (CSV) in a GMP-regulated environment
• MUST: Experience with inspection readiness activities to prepare regulated system environments for inspections
• MUST: Experience at IT/OT interfaces in production environments and project experience with global IT structures
• MUST: Very good English skills as well as German skills at C1 level
• Start: asap
• Duration: 3 months; extension option
• Scope: approx. 24-32 hours per week (3-4 days per week)
• Location: Remote with occasional on-site appointments in Frankfurt am Main
• Conditions: up to max. 90 €/h VHB Remote | possibly plus on-site surcharge
• Deadline: 06.11.2026

Project details

• Start: ab sofort
• Duration: 3 Monate
• Remote: hybrid
• Location: Frankfurt, Deutschland, DE
• Rate: 90-90 EUR/h
• Languages: German