Sr. IT\OT Project Manager

Job Summary:

We are seeking a highly experienced Senior IT\OT Project Manager with a strong background in pharmaceutical manufacturing, GMP compliance, and Operational Technology (OT). This role leads strategic IT and OT initiatives that support Corporate functions, manufacturing operations, automation systems, and regulatory compliance. The ideal candidate will have a proven track record of delivering complex projects in regulated environments, with expertise in both IT systems and OT infrastructure such as SCADA, PLCs, and MES.

Key Responsibilities:

·                Lead and manage cross-functional IT/OT projects in GMP-regulated pharmaceutical manufacturing environments.

·                Oversee implementation and integration of systems such as SAP, MES, LIMS, ERP, SCADA, DCS, QMS, and data historians.

·                Ensure all project activities comply with GxP, FDA 21 CFR Part 11, EU Annex 11, and data integrity standards.

·                Collaborate with Manufacturing, Quality Assurance, Engineering, and Automation teams to align IT/OT strategies.

·                Manage system validation (CSV), including documentation, testing, and change control.

·                Coordinate with vendors and integrators for OT system upgrades, cybersecurity, and lifecycle management.

·                Drive digital transformation initiatives including Industry 4.0, predictive maintenance, and smart manufacturing.

·                Monitor and report project progress, risks, and mitigation strategies to stakeholders and leadership.

·                Support audits and inspections by regulatory authorities.

Qualifications & Preferred Skills:

·                Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or related field.

·                7+ years of IT project management experience, with at least 3 years in a GMP-regulated pharmaceutical or biotech environment.

·                Preferred PMP, PRINCE2, or equivalent project management certification

·                Strong understanding of pharmaceutical manufacturing processes, automation, and OT systems.

·                Experience with system validation (CSV), GAMP 5, and regulatory compliance.

·                S/4HANA experience is a plus

·                Familiarity with both IT and OT cybersecurity best practices.

·                Excellent leadership, communication, and stakeholder engagement skills.

·                Experience with digital manufacturing, IoT, and smart factory technologies.