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The Opportunity:

The Manufacturing Engineer - Senior/Associate Principal is accountable for efficiently supporting manufacturing by providing GMP-compliant systems and processes. The individual in this role is responsible for leading continuous improvement initiatives, enhancing business processes, and serving as the system administrator for in-process testing equipment.

As the Manufacturing Engineer - Senior/Associate Principal, you are responsible for:

Lead and execute Continuous Process Improvements, CAPAs, and Changes, in assigned areas.

Align new improvement ideas according to the site’s priorities and capacity.

Improve employee capabilities and effectiveness through training, coaching, and assignments to lower-level manufacturing engineers and other employees.

Support inspection work such as presenting during inspections, responding to observations, and driving closure of inspection related Change Records.

Support Change Records Assessment and GMP documentation Review.

Responsible for providing support to the assigned manufacturing operations by developing, coordinating and facilitating medium to large projects to ensure planned, predictable production operations in compliance with GMP regulations.

Assist in the development of functional short and long-term goals, which support the manufacturing department and Site goals and objectives. Make recommendations on capital budget and improvement projects as well as feasibility review of suggestions from inside and outside the organization.

Lead project teams to troubleshoot medium to complex problems and support continuous process improvement. Facilitate root cause analysis (RCA) with input from SMEs, develop and implement change to improve performance.

Who You Are:

You hold a Degree/Diploma in Life Sciences or Engineering discipline (or equivalent). Preferably with 6 years or more of related manufacturing GMP experience and education in the Healthcare/Pharmaceutical/Biotech industries;

Experience in leading projects and supporting continuous process improvement;

Understanding of SAP and MES systems will be an added advantage.

Applies extensive theoretical and cross-functional expertise in the context of company objectives to independently address medium to complex problems.

Perform leadership role as needed by the business including interaction in the governance model.

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.