MSAT Process Engineering Lead

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The Position

The MSAT PE Lead/Subject Matter Expert (SME) is a pivotal technical role designed for talented individuals who bring unparalleled expertise in developing and integrating advanced biomanufacturing processes. The ideal candidate will be an influential collaborator within the team demonstrating significant technical depth capable of addressing complex challenges and advancing Roches process engineering strategy. By contributing at a strategic level the PE SME
will drive end-to-end process engineering projects across greenfield projects and routine operations reducing time-to-market improving efficiency and ensuring excellence throughout the product lifecycle. Additionally this role also encompasses responsibilities in single-use technology (SUT) implementation identifying opportunities for continuous improvement and ensuring that all technical documentation and knowledge transfer activities meet the highest
standards. With strong collaboration across cross-functional teams and internal and external stakeholders this role will keep providing comprehensive operational support driving technical innovation and optimizing manufacturing efficiency across the board.

Engineering Project Support & Operations:
Serve as a technical authority and strategic advisor for process engineering within the MSAT organization driving excellence in manufacturing processes validation and key performance monitoring to ensure compliance with cGMP/SHE standards and Roches quality policies.
Lead strategic project realization including facility design qualification and operational efficiency improvements.
Provide deep technical expertise in end-to-end process monitoring troubleshooting and optimization to maintain consistent product quality enhance efficiency and mitigate operational risks.
Champion process innovation and continuous improvement by identifying opportunities to optimize critical parameters enhance automation capabilities and improve product yield and reliability.
Manage complex troubleshooting efforts in production driving root-cause analysis risk assessment and implementing sustainable solutions to ensure minimal disruption to operations.

SUT Strategy & Implementation:
Provide critical support to the SUT SME for the design qualification and implementation of SUT systems into MSAT operations ensuring robust integration and compliance with regulatory expectations.
Deeply involved in SUT innovation optimization and risk mitigation across all phases of product lifecycle (NPI scale-up commercialization) to enhance operational efficiency reduce costs and accelerate time-to-market.
Contribute to SUT-related activities including extractables and leachables (E&L) studies compatibility assessments and risk mitigation to enhance operational efficiency and reduce time-to-market.

Influential Leadership & Global Interaction:
Demonstrates strong creative leadership mindset and skills with a proven ability to cultivate a forward-thinking outlook and effectively eliminate barriers to progress.
Collaborate with cross-functional teams (R&D QA Engineering Supply Chain) to optimize process transfers scale-up operations and address production bottlenecks.
Facilitate robust interaction and collaboration with global team members internal stakeholders and external partners to support the PE implementation and process optimization.
Provide timely updates promote effective knowledge sharing and establish efficient coordination mechanisms to drive alignment on key initiatives and project milestones.

Qualification and Experience
Bachelors Degree (Pharmaceutical / Biological is preferred) and above
At least 5 years of experience in Process Engineering with a minimum of 8 years MSAT/Technical or operation experience in the injection pharmaceutical industry MNC Bio-pharma preferred
Prior experience in people management is advantageous
Proven expertise in strategic project of Aseptic Filling facility including design commissioning & qualification
Hands-on experience in new facility startup readiness and operational ramp-up processes
Comprehensive knowledge of cGMP and regulations relevant to pharmaceutical industry especially in biological industry
Ability to think strategically translate high-level strategies into actionable plans and embrace agile methodologies to foster adaptability and effectiveness

Fluent communications skills in English 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.