Automation Project Manager – Pharma CAPEX

emagine; Region Sjælland; On-site; DKK 1,200,000 - 1,800,000; Full time

Job summary

emagine is seeking a Senior Automation/IT Work Package Owner/Project Manager to support a major API expansion in Kalundborg, Denmark. You will lead the Automation/IT work package during Conceptual Design, shaping scope and preparing a complete basis for Basic Design and potential execution.

You will own scopes across DCS, batch, historians, reporting, and IT/OT infrastructure, translating process needs into clear Automation/IT requirements and mitigating technical risks.

Qualifications

• 6+ years in Automation/IT CAPEX on pharma/biotech projects.
• Experience as Automation PM or Automation Lead.
• Strong DCS and batch automation experience.
• Familiar with GMP, GAMP 5, data integrity and CSV basics.

Responsibilities

• Own the Automation/IT work package including scope, deliverables, schedule and costs.
• Define scope across DCS, batch, historians, reporting and IT/OT infra.
• Translate process requirements into testable Automation/IT specs.
• Develop RFI/RFQ/RFP packages and evaluate supplier proposals.
• Review supplier designs and prepare for Basic Design and execution.

Skills

Automation CAPEX

Project management

DCS & batch automation

ISA-88/ISA-95 knowledge

RFI/RFQ/RFP packages

EPCM/Systems integrators

API/Drug Substance projects

Qualification & CSV basics

Tools

ABB 800xA

AVEVA PI

Job description

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