Senior/Principal Steward for Engineering Standards

GenentechHillsboro, OR
Onsite

About The Position

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. 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.

Requirements

  • Bachelor's or Master's Degree in Mechanical, Chemical, or Process Engineering
  • 5+ years of hands-on experience in Pharmaceutical/Life Sciences capital projects, manufacturing operations, or engineering environments
  • Proven matrix leadership and strategic stakeholder influencing capability, with the ability to build consensus among senior SMEs (up to C-level for Principal), challenge over-engineering constructively, and navigate complex cross-functional decision-making
  • Demonstrated expertise in Lean Six Sigma, Agile methodologies, or continuous improvement frameworks, with a structured, analytical mindset and strong quality orientation, potentially with a quantifiable track record of driving cost reduction and efficiency gains through standards optimization
  • Exceptional communication, facilitation, and organizational skills, with the ability to translate complex technical concepts into clear guidance, documentation, and influence organizational behavior change across diverse audiences and geographically dispersed teams
  • Independent and self-directed working style
  • Complete fluency in English (written and spoken)
  • Proven strategic advisory capability with the ability to assess emerging technologies and regulatory landscapes, establish forward-looking standards strategies, and position the organization ahead of industry trends
  • Track record of building and leading standards governance frameworks or technical communities of practice, with experience managing complex organizational change, resolving high-stakes technical disputes, and translating strategic directives into operational standards

Nice To Haves

  • Additional languages such as German or Mandarin are a plus
  • Proficiency in German, Mandarin, or other key operational languages is strongly preferred for global stakeholder engagement

Responsibilities

  • 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

Benefits

  • A discretionary annual bonus may be available based on individual and Company performance.
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