IT / OT Program Manager in GMP-regulated Environment

Project overview

Currently, I am looking for an IT / OT Program Manager in a GMP-regulated environment for my client:

Responsibilities

Please send me your profile including your hourly rate expectation via email. If your expertise lies in a different direction, please feel free to contact me as well, so we can find the right project for you together. I look forward to hearing from you!

• Support for ongoing IT and OT infrastructure initiatives
• Participation in the coordination of the CSV project in the area of Manufacturing Systems, laboratory systems, and connected production equipment
• Support in the creation and maintenance of integrated project plans, milestones, and dependencies
• Project-based coordination of collaboration between Global IT, Operations, Engineering, Quality, and external partners
• Participation in the optimization of project governance, reporting, and risk management processes
• Support in tracking risks, decisions, open points, and project dependencies
• Assistance in preparing steering committee documents and status reports
• Support in coordination with external service providers in the areas of automation and validation
• Participation in inspection preparation activities in regulated system environments
• Project-based promotion of communication between local and global project participants
• Support for knowledge transfer and transformation activities within ongoing projects

Project details

ASAP

3 months with option for extension

Expected 3-4 days/week

Primarily remote, with occasional presence required in Frankfurt am Main

Project Language: English and German

Must-Haves:

• Experience in project management of IT and OT projects in a regulated environment
• Experience in the pharmaceutical, biotechnological, or manufacturing sector
• Very good knowledge of stakeholder and project governance structures
• Experience in coordinating external service providers and international project participants
• Experience with Manufacturing Systems, infrastructure projects, or connected production systems
• Very good English skills
• Experience in Computer System Validation (CSV)
• Knowledge in GMP-regulated environments
• Experience with Inspection Readiness activities
• Experience at IT/OT interfaces in production environments
• Project experience with global IT structures
• Start: ab sofort
• Duration: 2 Monate
• Remote: hybrid
• Location: Frankfurt am Main, Deutschland, DE
• Rate: 125-125 EUR/h
• Languages: German