27 ago
|
Onesource Consulting
|
España
27 ago
Onesource Consulting
España
Senior Project Manager – Automation & OT Network Enablement | Pharmaceutical Manufacturing
We are seeking an experienced Senior Project Manager to lead Automation, Operational Technology (OT), and digital manufacturing initiatives within a highly regulated pharmaceutical manufacturing environment.
The role will initially support project initiation, business case development, governance, stakeholder alignment, funding approvals, and execution readiness, with the opportunity to continue as an OT Project Manager / Program Lead following project approval.
Key Responsibilities
- Lead project initiation, planning, governance, business cases, and funding approvals.
- Manage scope, budget, timelines, risks, dependencies, and stakeholder communications.
- Drive alignment across Manufacturing, Engineering, Automation, Quality, Validation, Cybersecurity, IT, and Business teams.
- Lead manufacturing automation, MES, digital manufacturing, and OT initiatives.
- Coordinate OT network implementation, IT/OT segregation, infrastructure readiness, equipment connectivity, and cybersecurity.
- Ensure compliance with GxP, CSV, data integrity, and regulatory requirements.
- Manage vendors and external partners throughout project execution.
- Prepare steering committee updates, executive presentations, and approval documentation.
Required Qualifications
- Bachelor's degree in Engineering, Computer Science, IT, Automation, or related field.
- 8+ years of project management experience in pharmaceutical, biotech, medical device, or regulated manufacturing.
- Strong knowledge of GxP, CSV, quality processes, OT networking, industrial cybersecurity, and IT/OT architecture.
- Experience with manufacturing automation, MES, industrial controls, or digital manufacturing.
- Strong leadership, stakeholder management, communication, and governance skills.
Preferred
- PMP certification.
- Experience with PLC, Historian, PI, or industrial control systems.
- Knowledge of FDA, EMA, Annex 11, 21 CFR Part 11, and pharmaceutical cybersecurity standards.
- Experience with facility expansions, manufacturing technology deployments, or OT network segregation.
Adecuado Candidate: A hands-on project leader who can bridge business, manufacturing, quality, automation, and IT teams and drive complex pharmaceutical automation initiatives from concept through execution.
📌 Project manager (España)
🏢 Onesource Consulting
📍 España