Automation Project Manager – Pharma CAPEX
Summary
Senior Project Manager leading Automation/IT work packages for a large-scale pharmaceutical API expansion project, managing DCS, batch systems, and IT/OT infrastructure while ensuring GMP compliance and coordinating with EPCM partners.
We are looking for a Senior Automation/IT Work Package Owner/ Project Manager to support a major API expansion project for a pharmaceutical client in Kalundborg.
The consultant will lead the Automation/IT work package during Conceptual Design, defining the scope and preparing a complete basis for Basic Design and potential later execution.
Main Responsibilities
Own the Automation/IT work package, including scope, deliverables, schedule, cost estimates, resources, risks, interfaces and changes
Define and coordinate scope across DCS, batch and recipe management, historians, reporting, IT/OT infrastructure and system integration
Translate process and engineering requirements into clear and testable Automation/IT requirements
Identify and resolve scope gaps, dependencies and technical risks
Develop RFI, RFQ and RFP packages
Define supplier boundaries, deliverables, milestones, testing and acceptance requirements
Lead technical bidder clarifications and supplier evaluations
Support supplier selection, award and mobilisation
Review supplier design documentation and prepare the work package for Basic Design and execution
Ensure compliance with GMP and relevant validation and data integrity requirements
Key Requirements
6+ years of Automation/IT CAPEX experience, including substantial pharmaceutical or biotechnology projects
Experience as an Automation Project Manager, Automation Lead or similar
Strong pharmaceutical DCS and batch automation experience
Knowledge of ISA-88, ISA-95, batch execution, recipe management and process historians
Proven experience developing RFI/RFQ/RFP packages and evaluating technical supplier proposals
Experience working with EPCM organisations, engineering partners and system integrators
Experience from major greenfield pharmaceutical projects
Good knowledge of GMP, GAMP 5, data integrity, CSV and CQV
Experience with API/Drug Substance projects, ABB 800xA, AVEVA PI, brownfield environments and previous Novo Nordisk projects would be an advantage.
Other Details
Start: asap
Duration: Until 30 September 2027
Location: Region Sjælland