Unit Lead Operational Engineering Steriles

Roche; Schweiz; On-site; CHF 150,000 - 190,000; Full time

Job summary

Roche Kaiseraugst seeks a Unit Lead Operational Engineering Steriles to provide process and automation engineering support for all sterile manufacturing units on site. You will be the main engineering contact for production equipment and ensure clear interfaces with Manufacturing Units and other departments.

You will lead the Steriles team, collaborate with CAPEX, Reliability, ITOT and manufacturing units, handle escalations, and drive lifecycle improvements while maintaining health authority

Qualifications

• Master’s degree in engineering (process, life science, chemical, electrical or automation) with ≥8 years in pharma, including CMO/large CAPEX projects.
• Leadership experience (direct or matrix) with Visionary, Architect, Coach, Catalyst and change leadership.
• Proven delivery of cross-functional CAPEX projects, regulatory know-how and participation in inspections.
• Solid knowledge of cGMPs, safety and quality systems, end-to-end thinking.
• Fluent in German and English (spoken and written) and strong stakeholder communication.

Responsibilities

• Lead process and automation engineering for steriles manufacturing units at Kaiseraugst.
• Collaborate with CAPEX Eng, Reliability, ITOT and steriles units to align engineering services.
• Manage escalations and implement effective solutions.
• Plan and coordinate within the unit to meet demand and priorities.
• Drive complex troubleshooting and lifecycle improvements with manufacturing units and support teams.
• Represent E&S Steriles during health authority inspections and audits; ensure clear communication among stakeholders.
• Provide leadership as part of the E&S Leadership Team, setting goals, coaching and driving improvements in quality, plant efficiency and cost-effectiveness.

Skills

Leadership

Project management

Regulatory knowledge

Quality systems

Stakeholder management

German & English

Education

Master’s degree in engineering

Job description

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 center (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 center 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 organizations 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 optimization.

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 organizations 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 organizational levels, fluent in German and English (written and verbal), and ideally experienced in process digitization 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.