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The Position

1. Primary Purpose of Job (Job Summary)

Roche is hiring for a greenfield facility in Shanghai and we are looking for an Engineer with strong deployment and hand-on experiences in Manufacturing IT System e.g SAP EWM and MES systems who act as process owner and collaborate with manufacturing users ITOT and Quality to work on the systems go-live and routine operations as well as continuous improvement.

The Aspire/MES Engineer is responsible for providing high-quality business analysis and management of manufacturing IT systems by closely collaborating with internal and external partners and communicating efficiently and timely to ensure the system meets business needs and compliance. Ensuring products are executed safely and timely in full compliance and consistency with GMP/ SHE requirements and Roches corporate principles quality policies and standards.

2. Principle Roles & Responsibilities / Accountabilities

Engineering Project Support and Operation Readiness:

• As a key role to establish an effective operation system in alignment with Roches standards including SAP EWM MES system.

• Collaborate with internal and external partners to design configure and implement the MES/Aspire system in alignment with GMP requirements and site-specific manufacturing processes.

• Lead and/or support validation activities (e.g. URS FRS IQ OQ PQ) to ensure MES/Aspire systems meet all regulatory and business standards.

• Coordinate integration of MES with other systems (e.g. ERP LIMS SCADA) and oversee functional testing to ensure seamless system operation.

• Develop and maintain comprehensive documentation including validation system workflows and operational procedures.

• Provide MES/Aspire system training to production-related staff to ensure efficient and compliant system use during operations.

• Partner with global teams F&E IT and QA to ensure proper alignment of the MES/Aspire system with technical and regulatory expectations.

• Perform other duties as assigned.

Routine Operation:

• Join and approve IT Change Control Board (CCB) and Change Request Forms (CRF) ensuring changes meet local business needs and standards minimal impact to production and full compliance with change control.

• Lead or participate in Global and local projects related to production IT systems to ensure business goals are met.

• Serve as the primary point of contact for MES/Aspire systemscommunicate with production business departments to gather and analyze their needs ensure IT systems meet business requirements support and enhance business efficiency and comply with GxP regulations.

• Ensure data accuracy integrity and traceability within MES/Aspire systems supporting inspection readiness.

• Assess the performance of existing production IT systems propose improvements and new system requirements based on business needs and assist in selecting suitable technical solutions.

• Analyze current business processes identify areas for improvement and develop and implement

• optimization plans.

• Utilize data analysis tools to generate insights reports supporting business decisions and process optimization.

• Manage user permissions to ensure only authorized personnel can access corresponding data and functions.

• Develop and maintain business continuity plans to ensure production and business activities can continue in emergencies.

• Participate in periodical audit trail review to ensure data and operational traceability complying with GxP regulations.

• Support IT system training for production and business teams assisting them in effectively utilizing IT system features.

• Assist in identifying and resolving IT system issues in business applications providing continuous support and improvement suggestions.

• Related IT system operations such as SAP EWM MES Veeva Cornerstone.

• Perform other duties as assigned.

3. Qualification and Experience

Education/Qualifications

• Bachelors Degree in computer science Information Technology Pharmaceutical / Biological is preferred and above.

Job Required Competencies

• 5 or more years MES implementation or support experience in the injection pharmaceutical industry MNC Bio-pharma preferred.

• Experienced in strategic project of Manufacturing IT system (MES Aspire) including design commissioning & qualification is preferred.

• Strong understanding of MES configuration workflows and validation in computer system validation (CSV) and change management processes especially in biological industry.

• Working knowledge of GMP regulations for automated systems (e.g. Annex 11 21 CFR Part 11).

• Fluent communications skills in English is preferred and the ability to effectively communicate collaborate and foster positive interactions with team members and stakeholders.

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.