Senior Process Engineer - Process Technology Package Owner

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About the Position:
Roche Diagnostics Suzhou is seeking an experienced Senior Process Engineer to take on the role of Process Technology Package Owner. This position will play a critical role in the design, build, commissioning, and handover of process equipment for the diagnostics and pharmaceutical industry. The focus includes machinery equipment like filling lines, assembly  and packaging machines as well as compounding stations for solution mixing and integrating automation and startup processes.

We are looking for a hands-on individual with extensive experience in the mechanical design, engineering, fabrication, and commissioning of process equipment, including expertise in coding, automation and electrical systems. Knowledge of Roche-specific directives (K-directives, Engineering, and Quality standards) is essential for this role.

Key Responsibilities:

• Act as the Process Technology Package Owner, leading the entire lifecycle of equipment projects—from initial design to final handover.

• Design, fabricate, and commission complex process systems for diagnostic and pharmaceutical applications.

• Drive automation integration and electrical system implementation within process equipment.

• Manage supplier qualification and oversee the fabrication and delivery of equipment packages.

• Execute FAT (Factory Acceptance Testing), commissioning, startup, and qualification efforts for process systems.

• Ensure compliance with Roche K-directives, Engineering Standards, and Quality Standards.

• Collaborate with cross-functional teams, including mechanical, electrical, and automation experts, as well as external vendors.

• Provide on-site support and technical leadership during commissioning and qualification phases.

• Contribute to knowledge and technology transfer as part of Roche’s global engineering network.

Scope of Work:

• Conceptualize and lead process design, development, and optimization.

• Perform process analysis to achieve optimal performance in manufacturing.

• Work efficiently within agile, self-organized teams, requiring advanced self-management and collaboration capabilities.

• Participate in GMP audits and inspections, ensuring compliance with regulatory requirements.

• Act as a liaison between internal departments, suppliers, and global stakeholders.

Qualifications:

Education:

• Master in Process and Chemical Engineering or Master in Mechanical Engineering with experience in the diagnostic or pharmaceutical industry.

• Additional profession in Electrical Engineering and as an Electrical Technician.

Additional Relevant Training & Certifications:

• Welding Specialist

• Process Automation

• GAMP & GMP expertise 

• SHE on construction sites

Skills & Expertise:

• Hands-on experience in the design, manufacturing, and commissioning of process equipment.

• Technical expertise in automation technologies (e.g., Siemens PCS7, S7, WinCC).

• Proficient in electrical system integration within process technologies.

• Strong understanding of GMP, GAMP, and process qualification standards.

• Familiarity with process equipment relevant to diagnostics and pharmaceuticals, including compounding stations and liquid dosing systems.

• Expertise with CAD Autodesk Inventor (Advanced Knowledge).

• Advanced knowledge of PRO/II Process Simulation and MathWorks Matlab.

• Basic knowledge of programming in Python, C, C++, and working with Assembler systems.

• Extensive experience leading and collaborating on multinational projects globally, ensuring effective communication and cross-cultural teamwork.

• Comprehensive understanding of Roche K-directives and engineering quality standards.

• Experience in teamwork, supplier coordination, and project execution.

Language Requirements:

• Fluent English (essential).

• German or Chinese skills are preferred, but not essential.

Preferred Attributes:

• Hands-on, problem-solving mindset with a passion for innovation.

• Strong project management, communication, and organizational skills.

• Willingness to travel and work across different sites globally.

What We Offer:

• A highly collaborative and innovative work environment.

• Opportunities to work on impactful projects that support diagnostics and pharmaceuticals globally.

• Engagement in a supportive network, encouraging professional and technical growth.

General Information:

• Location: Suzhou, China

• Workload: 100%

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.