Senior/Principal Steward for Engineering Standards
GenentechAbout the role
This role is a critical part of our Engineering team which is dedicated to ensuring technical consistency, regulatory compliance, and operational efficiency across all manufacturing and capital projects. As a Senior/Principal Engineering Standards Steward, you will serve as the custodian and strategic driver of our organization's technical specifications, design guidelines, and standard operating procedures—bridging cross-functional teams to embed best practices and prevent over-engineering that inflates costs. Working collaboratively with Subject Matter Experts, Quality, EHS, Operations, and external partners, you will champion the adoption and continuous improvement of engineering standards that enable innovation while maintaining the highest standards of GMP compliance and Lean optimization.
The Opportunity
As the Senior/Principal Engineering Standards Steward, you will own the complete lifecycle of our technical standards portfolio—from creation and validation through implementation and continuous refinement—while serving as the primary advisor and custodian ensuring alignment across all engineering disciplines and projects. Key responsibilities include:
Establish and manage the central repository for all engineering standards (Mechanical, Electrical, Process, Automation, etc.) with clear version control and change history
Drive standards relevance and currency through a formal review cadence that monitors industry trends and regulatory changes, triggering timely SME input to prevent obsolescence
Lead end-to-end implementation strategies for new or revised standards, including development of training materials, e-learning resources, user guides, and facilitation of workshops to ensure seamless adoption across projects and operations
Challenge over-engineering and gold-plating by partnering with project teams and SMEs to justify high-cost specifications and ensure standards reflect "fitness for purpose" rather than maximalist designs
Translate field feedback into continuous improvement by facilitating lessons-learned sessions, performing root-cause analysis, and iteratively refining standards to prevent recurring mistakes
Align standards with GMP requirements in close partnership with Quality, ensuring regulatory compliance without unnecessary bureaucratic layers
Resolve complex technical obstacles through workshops, design reviews, and consensus-building across SMEs, with the authority to escalate and document trade-offs that support project momentum
Who You Are
Requirements for Senior:
Bachelor's or Master's Degree in Mechanical, Chemical, or Process Engineering with 5+ years of hands-on experience in Pharmaceutical/Life Sciences capital projects, manufacturing operations, or engineering environments
Proven matrix leadership and stakeholder influencing capability, with the ability to build consensus among senior SMEs, challenge over-engineering constructively, and navigate cross-functional decision-making with minimal escalation
Demonstrated expertise in Lean Six Sigma, Agile methodologies, or continuous improvement frameworks, with a structured, analytical mindset and strong quality orientation
Exceptional communication, facilitation, and organizational skills, with the ability to translate complex technical concepts into clear guidance, FAQs, and user-centric documentation for diverse audiences
Independent and self-directed working style with proficiency in English (written and spoken); additional languages such as German or Mandarin are a plus
Requirements for Principal:
Bachelor's or Master's Degree in Mechanical, Chemical, or Process Engineering with 8+ years of hands-on experience in Pharmaceutical/Life Sciences capital projects, manufacturing operations, or engineering environments
Advanced matrix leadership and strategic stakeholder influencing capability, with proven ability to build consensus among C-level and senior SME stakeholders, challenge over-engineering at enterprise scale, navigate complex cross-functional decision-making with autonomy, and mentor junior engineers in standards governance and technical leadership
Demonstrated expertise in Lean Six Sigma, Agile methodologies, and continuous improvement frameworks, combined with a strategic analytical mindset, strong quality orientation, and quantifiable track record of driving cost reduction and efficiency gains through standards optimization
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