Senior Project Manager – MES

Ampstek; Vitoria; A distancia; EUR 80.000 - 100.000; Jornada completa

Descripción de la vacante

A leading technology firm is seeking a Senior Project Manager to lead complex Manufacturing Execution Systems (MES) programs within the Pharmaceutical Manufacturing division. The ideal candidate will have extensive experience in MES, specifically with Rockwell Automation's PharmaSuite, and be adept at managing cross-functional projects in compliance with GxP standards. This role is pivotal in ensuring operational excellence and quality in a highly regulated environment.

Formación

• Minimum 7+ years of proven experience in project management.
• Demonstrated expertise in Rockwell PharmaSuite.
• Strong understanding of GxP, CSV, and data integrity principles.
• Experience managing global projects with distributed teams.
• Exceptional communication, leadership, and problem-solving skills.

Responsabilidades

• Lead the end-to-end delivery of MES programs.
• Define project scope, timelines, and deliverables.
• Drive governance and track progress against milestones.
• Manage risks and ensure transparent communication.
• Champion quality-by-design throughout the system lifecycle.

Conocimientos

Project Management

Pharma Manufacturing IT systems

Rockwell Automation PharmaSuite

GxP compliance

Data integrity principles

Communication

Leadership

Educación

Project Management certifications (PMP, PRINCE2, Agile PM)

Herramientas

DCS

PLCs

LIMS

ERP integrations (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.