Ampstek

Project Manager

Posted: 9 hours ago

Job Description

Job Title: Senior Project Manager – Pharma Manufacturing (MES / PharmaSuite)Location: Poland, Spain (work From Home)For Poland - 265 K PLN per annumFor Spain – 60K Euro per annum Experience Level: Senior (10+ years and not more than 20 yrs overall) About the RoleWe 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. Key ResponsibilitiesProject Leadership & DeliveryLead 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 OversightProvide 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. Required QualificationsMin 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.

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