Overview
In this role you lead end-to-end process engineering for a major pharma capital project, from concept to handover. You will ensure safe, compliant, scalable manufacturing systems that meet quality and regulatory standards. You work across Engineering, Operations, Quality, Automation, and Science & Technology to drive critical project decisions and operational readiness. Your impact spans device design, risk assessment, and commissioning to support patient manufacturing.
Verantwortungsbereiche
- Lead process engineering activities from concept through startup and handover to Operations
- Translate manufacturing needs into robust process and equipment designs aligned with safety, quality, and compliance
- Own deliverables such as process design documentation, equipment specs, process risk assessments, and control strategies
- Foster cross-functional collaboration across Engineering, Operations, Quality, CQV, Automation, and external partners
- Ensure GMP compliance and adherence to engineering standards and regulatory expectations
- Lead technical reviews, risk assessments, and design decisions for project execution and readiness
- Guide equipment selection, commissioning, qualification, and startup activities
- Provide leadership to Suite Leads and Process Package Owners ensuring alignment across workstreams
- Support governance, issue resolution, escalation, schedule adherence, and knowledge transfer to site operations
Zentrale Anforderungen
- Bachelor in Chemical Engineering
- Extensive experience in pharmaceutical, biotech, vaccine, or other highly regulated manufacturing
- Proven success leading process engineering workstreams on complex capital projects
- Strong GMP, process design, commissioning, qualification, and validation knowledge
- Experience driving decisions in large cross-functional project teams
- Excellent communication, stakeholder management, and leadership skills
- Ability to navigate complexity, influence across functions, and focus on business outcomes
- strong communication
- stakeholder management
- leadership
- GMP compliance
- process design
- commissioning and qualification
GES Process Lead (f/m/d) (MUSE) - Associate Director in Unterschleißheim Arbeitgeber: Merck Sharp & Dohme (MSD)
Als Arbeitgeber in der Landwirtschaft bieten wir Ihnen die Möglichkeit, in einem dynamischen und innovativen Umfeld zu arbeiten, das auf die Bedürfnisse moderner Tierhaltungsbetriebe ausgerichtet ist. Unsere Unternehmenskultur fördert Teamarbeit und kontinuierliches Lernen, während wir Ihnen durch gezielte Schulungen und Entwicklungsmöglichkeiten helfen, Ihre Karriere voranzutreiben. Zudem profitieren Sie von flexiblen Arbeitsarrangements und der Chance, aktiv zur Verbesserung des Gesundheitsmanagements in der Schweinehaltung beizutragen.
Kontaktdaten:
Merck Sharp & Dohme (MSD) Recruiting-Team