Process Data and Systems Management Engineer

Genentech

2d • Hybrid

About The Position

We are seeking a dedicated Process Data and Systems Management Engineer to join our team as a key contributor to Roche's manufacturing excellence and data integrity initiatives. In this role, you will be instrumental in building and maintaining high-quality process recipes within our Basecamp 2.0 system, ensuring compliance with GMP standards, and fostering a culture of data stewardship across our organization. This position offers the opportunity to work at the intersection of operations, technology, and quality, directly supporting our site's manufacturing objectives while driving continuous improvement in our data management practices.

Requirements

• 2-4 years of related work experience with a Bachelor's degree or 0 - 2 years of related work experience with a Masters degree.
• Educational background in science: Engineering, Chemistry, Biochemistry, Biological Sciences, or similar
• Experience leading multifunctional teams
• Experienced in biologics manufacturing operations (in drug substance or drug product for the site)
• Prior experience with process tech transfers, process validation, master data management, recipe management

Responsibilities

• Lead Recipe Data Excellence: Build and maintain General and Site Recipes for processes and products in Basecamp 2.0, serving as a key functional contributor to recipe data specifications, quality standards, and compliance requirements
• Drive Data Stewardship Culture: Collaborate with Recipe Data Steward Leads, Business Process Managers, and Business Process Owners to embed best practices in data integrity and establish a culture of recipe data excellence across the organization
• Ensure Data Quality & Compliance: Perform regular audits and validation checks to guarantee recipe data is accurate, complete, and reliable for business-critical processes while maintaining full GMP compliance
• Support & Develop Teams: Coach and upskill local Basecamp 2.0 users on effective data stewardship practices, train new staff, and champion principles of data integrity across multifunctional teams
• Resolve Data Constraints: Identify and resolve data constraints, maintain metadata integrity, and work to eliminate gaps in systems and procedures that impact operational efficiency
• Cross-Functional Collaboration: Partner with other departments to address technical issues, meet critical deadlines, and ensure seamless integration of data management practices across the manufacturing network
• Maintain Operational Readiness: Support the department in achieving corporate goals and site objectives while ensuring inspection readiness and staying current with mandatory training and regulatory requirements

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level