Unit Lead Operational Engineering Steriles

F. Hoffmann-La Roche AG; Kaiseraugst; Vor Ort; CHF 150.000 - 230.000; Vollzeit

Zusammenfassung

Roche Kaiseraugst seeks a Unit Lead Operational Engineering Steriles to provide process and automation engineering support for all sterile units. You will ensure clear interfaces with manufacturing units and other functions, drive improvements, and manage escalations to deliver reliable production services.

With 8+ years in pharma and a Master’s in engineering, you will lead the Steriles team, collaborate across CAPEX projects, and represent the department in health authority inspections while

Qualifikationen

• Master's degree in engineering with ≥8 years in pharma, including internal/CMO environments.
• Strong leadership experience aligned with change and risk management.
• Proven delivery of cross-functional and CAPEX projects and regulatory changes.
• Solid understanding of safety, quality systems and cGMPs, end‑to‑end mindset.
• Fluent in German and English; excellent stakeholder communication.

Aufgaben

• Provide process and automation engineering support for all sterile units at Kaiseraugst site.
• Lead interfaces with Manufacturing Units and other departments; escalate and resolve issues.
• Coordinate demand planning within the unit and drive lifecycle improvements.
• Represent the department during health authority inspections and audits.
• Lead and mentor team members; contribute to production quality and efficiency.

Kenntnisse

Leadership

Engineering expertise

Regulatory knowledge

Stakeholder management

Process optimization

Ausbildung

Master's degree in engineering

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 With its 1,400 employees, the Kaiseraugst production centre (PT Manufacturing) ensures uninterrupted patient care with high-quality medicines. We stand for the highest standards of pharmaceutical manufacturing, Roche's largest, most innovative packaging centre and serving more than 120 countries. For a successful production site Kaiseraugst Engineering & SHE (E&S) advances and enables innovation and improvement by using science, technical knowledge and predictive services. Our key success factors for sustainable and compliant asset performance are continuous improvement of our processes, agile employees and passion.

The Opportunity As Unit Lead Operational Engineering Steriles you are responsible for providing process and automation engineering support for all sterile manufacturing units on the Kaiseraugst site. In that role you and the Steriles team are the first port of call for all engineering requirements related to the production equipment. As Unit Lead you will be responsible to ensure that the interfaces to other departments are clear and our internal clients (the Manufacturing Units) are happy with the service they receive. Functional and knowledge leadership for process and automation Engineering in the steriles production buildings. Close collaboration with partner organisations such as CAPEX Engineering, Reliability, ITOT and the steriles Manufacturing Units. Deal with escalations and ensure adequate solutions are implemented. Demand planning and coordination within the unit. Ensure the unit drives complex troubleshooting and lifecycle process improvements, leveraging expert knowledge in collaboration with manufacturing units and support teams, while promoting advanced methods and tools and integrating them into daily operations. Representation of the Operational Engineering Steriles department during health authority inspections and audits, including preparation, presentation, support, and follow-up, while ensuring effective communication and information flow among all stakeholders (manufacturing units, site support functions, global teams, quality divisions, suppliers). Leadership responsibilities, including membership in the E&S Leadership Team, setting goals, driving development, coaching and mentoring team members, assessing performance, and identifying and implementing improvements to production quality, plant efficiency, cost-effectiveness, and overall process optimisation.

Who you are Education & Experience: Master's degree in engineering (process, life science, or chemical engineering, electrical or automation), preferably with postgraduate training or a doctorate, and ≥8 years of experience in the pharmaceutical industry, including internal and contract manufacturing organisations and large CAPEX project execution, with several years in engineering and CMO environments and proven ability to reduce complexity.

Leadership & Change Management: Several years of leadership experience (direct and/or matrix) with strong creative leadership aligned with the VACC model (Visionary, Architect, Coach, Catalyst) and a track record of driving change courageously while balancing risks and ensuring successful pacing, demonstrating openness to recognizing and leveraging opportunities from change.

Project & Regulatory Expertise: Proven delivery of cross‑functional and CAPEX projects, strong knowledge of health authority requirements, and experience executing registration‑relevant technical changes, as well as participation in health authority inspections or audits.

Operational & Quality Knowledge: Solid understanding of safety, quality systems, and quality assurance, including application of current Good Manufacturing Practices (cGMPs) and an entrepreneurial, systemic 'end-to-end' mindset, with the ability to perform consistently in dynamic environments.

Stakeholder & Communication Skills: Strong stakeholder management, ability to communicate and influence across all organisational levels, fluent in German and English (written and verbal), and ideally experienced in process digitisation initiatives.

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.