Senior Project Manager (MES / PharmaSuite)

Adroit People Limited (UK); Vitoria; A distancia; EUR 80.000 - 110.000; Jornada completa

Descripción de la vacante

A leading recruitment firm is seeking a Senior Project Manager to lead MES programs within Pharma Manufacturing. The ideal candidate will have over 7 years of project management experience, specifically in Pharma IT systems, with expertise in Rockwell Automation's PharmaSuite. This role involves overseeing the complete project lifecycle, managing global teams, and ensuring compliance with GxP regulations. An opportunity to drive operational excellence in a fast-paced environment.

Formación

• Min 7+ years of experience in project management focused on Pharma Manufacturing IT systems.
• Expertise in Rockwell Automation PharmaSuite implementation.
• Strong understanding of GxP, CSV, and data integrity principles.

Responsabilidades

• Lead the delivery of MES programs from initiation through deployment.
• Define project scope and deliverables in collaboration with stakeholders.
• Manage risks, issues, and dependencies ensuring transparent communication.

Conocimientos

Project management

Rockwell Automation PharmaSuite

GxP regulations

CSV principles

Leadership

Communication

Educación

Project Management certifications (PMP, PRINCE2, Agile PM)

Descripción del empleo

Role

Job Title: Senior Project Manager – Pharma Manufacturing (MES / PharmaSuite)

Location

Poland / Spain (Remote)

Permanent Full Time Employment

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.