Senior Project Manager – MES

Ampstek; Madrid; A distancia; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

A leading technology company is seeking a Senior Project Manager to lead large-scale Manufacturing Execution Systems (MES) programs in the Pharmaceutical Manufacturing division. The ideal candidate will have over 7 years of project management experience, expertise in Rockwell Automation’s PharmaSuite platform, and a strong understanding of GxP regulations. This role offers the opportunity to manage multi-site projects and ensure compliance and operational excellence.

Formación

• 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.
• Exceptional communication, leadership, and problem-solving skills.

Responsabilidades

• Lead the end-to-end delivery of MES programs from initiation to deployment, validation, and hypercare.
• Define project scope, timelines, and deliverables in collaboration with stakeholders.
• Provide subject matter leadership for Rockwell PharmaSuite MES implementations.

Conocimientos

Project management

Pharma Manufacturing IT systems

GxP compliance

Rockwell Automation PharmaSuite

Leadership

Problem-solving skills

Educación

Project Management certifications (PMP, PRINCE2, Agile PM)

Herramientas

DCS

PLCs

LIMS

ERP integrations (e.g., SAP PP-PI)

Descripción del empleo

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.