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 adecuado 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.
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