Senior Project Manager – MES

Work Location : Poland OR Spain (Remote). Candidate should be located in any of these 2 locations or willing to relocate can apply

About the Role

We are seeking an accomplished Senior Project Manager to lead and deliver complex, large-scale Manufacturing Execution Systems (MES) programs within our Pharmaceutical Manufacturing division. This role requires a unique combination of technical expertise, strategic leadership, and regulatory awareness to drive initiatives that directly support operational excellence, product quality, and compliance in a GxP-regulated environment.

The ideal candidate will possess deep domain experience in MES, particularly with Rockwell Automation’s PharmaSuite platform, and a demonstrated ability to manage multi-site, cross-functional projects in alignment with stringent validation and compliance standards.

Key Responsibilities

Project Leadership & Delivery

Lead the end-to-end delivery of MES programs from initiation through deployment, validation, and hypercare.

Define project scope, timelines, and deliverables in collaboration with stakeholders from IT, manufacturing, quality, and automation.

Drive governance, track progress against milestones, and ensure projects are delivered on time, within scope, and on budget.

Proactively manage risks, issues, and dependencies, ensuring transparent communication and timely escalation.

Technical & Functional Oversight

Provide subject matter leadership for Rockwell PharmaSuite MES implementations, including configuration, integration, and validation phases.

Collaborate with engineering and manufacturing teams to define and optimize business processes supported by MES.

Ensure all system changes comply with Computer System Validation (CSV), GxP, and data integrity standards.

Stakeholder Management & Communication

Serve as the primary liaison between business sponsors, global delivery teams, and third-party vendors.

Conduct regular status reviews, steering committee presentations, and project health assessments.

Foster collaboration and alignment across global sites to ensure consistent delivery practices.

Quality, Compliance & Continuous Improvement

Champion quality-by-design and validation best practices throughout the system lifecycle.

Drive process improvement initiatives to enhance efficiency, compliance, and operational readiness.

Stay current with evolving regulatory requirements, industry trends, and MES technologies to influence roadmap planning.

Required Qualifications

Min 7+ years of proven experience in project management with a focus on Pharma Manufacturing IT systems or MES implementations.

Demonstrated expertise in Rockwell Automation PharmaSuite (implementation, customization, and validation).

Strong understanding of GxP, CSV (Computer System Validation), 21 CFR Part 11, and data integrity principles.

Excellent understanding of pharmaceutical production processes, batch management, and shop floor systems integration.

Proven experience managing global projects with distributed teams and multiple stakeholders.

Exceptional communication, leadership, and problem-solving skills.

Project Management certifications such as PMP, PRINCE2, or Agile PM are preferred.

Prior experience working with leading pharma or biotech organizations will be a strong advantage.

Preferred Attributes

Hands-on experience with related technologies such as DCS, PLCs, LIMS, or ERP integrations (e.g., SAP PP-PI).

Ability to balance technical depth with executive-level communication and stakeholder influence.

A proactive, structured, and quality-focused mindset with a strong sense of accountability.