Packaging Engineering Expert (temporary for 14 months)

F. Hoffmann-La Roche AG; Basel; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Roche is seeking a Packaging/Mechanical Engineer with 2–3 years of pharma cold-chain experience to safeguard our supply chain and power smart, digitalized manufacturing logistics. Bachelor’s or Master’s in Packaging or Mechanical Engineering; fluent English; German a plus.

Knowledge of ISTA 7D, ASTM, ISO, and qualification processes is required. The role focuses on design and execution of GMP qualification studies, cross-functional collaboration, and driving digital packaging initiatives to

Qualifikationen

• Bachelor’s or Master’s in Packaging Engineering, Mechanical Engineering, or a related field.
• 2–3 years of pharma cold-chain experience.
• Fluent English; German proficiency is a plus.
• Technical writing and cross-functional collaboration required.
• Knowledge of ISTA 7D, ASTM, ISO and qualification processes.

Aufgaben

• Design and execute GMP qualification studies for packaging and cold-chain.
• Lead cross-functional efforts across manufacturing, QA, and regulatory.
• Support digital transformation initiatives including smart packaging and IoT monitoring.
• Ensure regulatory compliance and robust qualification documentation.

Kenntnisse

Pharma cold-chain experience

Technical writing

Cross-functional collaboration

Problem solving

English fluency

Ausbildung

Bachelor’s or Master’s in Packaging Engineering

Mechanical Engineering

Tools

ISTA 7D

ASTM standards

ISO standards

IoT integration

Jobbeschreibung

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position Pharma Technical Operations (PT) is responsible for manufacturing, supply chain, and quality across the pharmaceutical network. Within PT, PTT (MSAT & Engineering) is responsible for ensuring that PT stays at the forefront of technology in our facilities and supports our robust processes & efficient operations. We focus on integrating product health, process health with equipment fit for purpose, and facility readiness in support of the manufacturing network. Global Device, Packaging and Distribution MSAT ensures our device-related products including platforms and packaging systems are robustly engineered, efficiently manufactured, and safely delivered and maintained. The Packaging & Distribution Engineer leads global projects in cold chain, thermal shipping qualification, tertiary packaging, and IoT monitoring across clinical and commercial supply chains. The Opportunity Operating within the gMSAT / Distribution Technology group, the role drives smart manufacturing, rigorous packaging qualification, and the comprehensive digital transformation of the supply chain.

Cold Chain & Qualification: Design and execute end-to-end GMP qualification studies using industry standards (ISTA 7D, ASTM). Establish thermal profiles, perform risk assessments, and leverage vendor data to ensure robust supply chain integrity.

Digital Transformation: Drive the digital transformation of the global supply chain by piloting and implementing smart packaging, active IoT monitoring, and data-driven distribution logistics.

Lifecycle & RCA: Manage system lifecycle, conduct change impact assessments, lead Root Cause Analysis (RCA) for temperature excursions, and oversee system decommissioning.

Regulatory & Quality: Prepare regulatory submission content, ensure strict Good Distribution Practice (GDP) compliance, and support internal/external quality audits.

Cross-Functional Leadership: Align global logistics and supply chain, internal/CMO manufacturing, Procurement, Quality, and Regulatory Affairs network partners.

Who you are

You are an innovative Packaging or Mechanical Engineer with 2–3 years of pharma cold-chain experience willing to safeguard our supply chain integrity and power the future of smart, digitalized manufacturing logistics. Bachelor’s or Master’s in Packaging Engineering, Mechanical Engineering, or a related field. 2–3 years in pharmaceutical packaging, cold chain, GDP guidelines, and thermal shipper qualification. Direct experience with IoT integration and supply chain digitalization is a plus. Deep knowledge of ISTA 7D, ASTM, ISO, and rigorous validation/qualification process. Technical writing, complex problem-solving, cross-functional collaboration, and the ability to define project execution plans. Fluent English (required); German proficiency is a plus.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.