Engineer

Career Category

Job Description

Position Summary

The Engineer - Engineering Technical Authority (ETA) will support the development, implementation, and continuous improvement of engineering practices, standards, and processes that enable effective Engineering Project Delivery.

This role will work closely with Engineering Technical Authorities, subject matter experts (SMEs), project teams, and global engineering stakeholders to develop and maintain the Engineering Design Library and Engineering Project Delivery framework.

A key focus of the position will be translating engineering knowledge, requirements, lessons learned, and industry practices into clear and effective engineering standards, specifications, procedures, SOPs, guidance documents, and tools. The role will also support the organization, governance, accessibility, and lifecycle management of engineering knowledge and controlled documentation.

The ideal candidate has an engineering or related technical background, strong technical communication and information-management skills, and a foundational understanding of biotechnology, pharmaceutical manufacturing, or another regulated engineering environment.

Key Responsibilities

Engineering Technical Authority & Engineering Design Library

• Support Engineering Technical Authorities and SMEs in the development and maintenance of engineering standards, specifications, design guidelines, and other Engineering Design Library content.
• Coordinate with engineering disciplines to capture technical requirements and translate SME knowledge into clear, actionable engineering documents without changing technical intent.
• Review existing engineering documents and identify opportunities for improvement, consolidation, clarification, and standardization.
• Support periodic review and revision of Design Library documents to incorporate lessons learned, technology changes, industry practices, and evolving business needs.
• Promote consistency in engineering requirements, terminology, document structure, and application across engineering disciplines and sites.
• Support governance and lifecycle management of engineering standards, specifications, procedures, and related technical content.
• Support organization, metadata, searchability, and accessibility of Engineering Design Library content.

Engineering Project Delivery

• Support development and continuous improvement of Engineering Project Delivery processes, procedures, SOPs, guidance documents, templates, and tools.
• Work with project delivery and engineering SMEs to document effective practices across the project lifecycle.
• Support development and revision of engineering requirements associated with project planning, design, execution, commissioning, qualification, and turnover.
• Capture lessons learned from engineering projects and support incorporation of those lessons into engineering standards and project delivery practices.
• Help identify opportunities to simplify, standardize, and improve engineering processes and project execution.

Technical Documentation & Change Management

• Author and revise engineering standards, specifications, SOPs, procedures, technical guidance, and related engineering documents.
• Translate complex technical information into clear, concise, and actionable engineering requirements.
• Facilitate working sessions with SMEs to capture technical knowledge and develop structured engineering content.
• Coordinate document reviews and work with stakeholders to resolve comments and reach technical alignment.
• Manage multiple document revisions, reviewers, deadlines, and approval workflows.
• Support communication of Engineering Standards and Specifications (ESS) changes to affected stakeholders.
• Develop process maps, workflows, tables, diagrams, and other tools to improve communication of engineering requirements and processes.
• Research applicable external codes, standards, and industry guidance to support document development. Technical interpretation and ownership of requirements remain with the designated ETA SME.

Working Hours & Global Collaboration Model

The role should be structured to provide reliable support to U.S., Europe, and Asia stakeholders. The working model may be established as Hybrid. The selected model should preserve protected time for focused document work while providing planned overlap for SME reviews, global meetings, and ESS change communications.

Model

Work Hours

Global Overlap Reference*

Recommended Use

HYBRID

Mon-Thu: 9:30 AM-3:30 PM at site, with split remote work before/after site hours; Fri: 9:00 AM-6:00 PM ET

Per AIN reference: 3 hr with PT; 3 hr with ET; 5 hr with EU; 6 hr with Singapore

Best when on-site ETA/SME interaction is important while retaining global collaboration flexibility.

*Global overlap periods are intended as planning references. Specific meeting windows may vary based on stakeholder location, project needs, and critical SME availability.

Skills & Qualifications

• Bachelor's degree in engineering or a related technical discipline. Degrees or demonstrated experience in technical communications or information management may also be considered where accompanied by sufficient engineering or technical experience.
• Experience working with engineering standards, specifications, procedures, technical documentation, or controlled document systems in a regulated or highly structured environment.
• Strong technical writing, editing, document-control, and information-organization skills.
• Ability to work effectively with subject matter experts and translate technical inputs into clear, usable document content without changing technical intent.
• Experience with Microsoft 365, SharePoint, document libraries, metadata/search concepts, and collaboration tools or equivalent engineering knowledge platforms is desirable.
• Strong organizational skills with the ability to manage multiple document revisions, deadlines, reviewers, and approvals simultaneously.
• Comfort working across global time zones and adjusting meeting windows when critical SME or stakeholder participation is required.
• Working knowledge of how external codes, standards, and industry guidance influence engineering requirements; the role is expected to coordinate and research, while technical ownership remains with the designated ETA SME.
• Foundational knowledge of biotechnology, pharmaceutical manufacturing, life sciences, or another regulated manufacturing environment is preferred.
• Familiarity with engineering drawings, P&IDs, equipment specifications, design documentation, or capital-project engineering deliverables is desirable.

Key Competencies

Engineering & Technical Understanding - Applies engineering fundamentals and technical knowledge to understand requirements, recognize gaps, and effectively engage the appropriate SMEs.

Technical Communication - Translates complex engineering concepts and SME input into clear, concise, and actionable standards, specifications, procedures, and guidance without altering technical intent.

Technical Curiosity - Quickly develops an understanding of unfamiliar technologies, systems, engineering disciplines, codes, and standards and asks effective questions to clarify requirements.

Knowledge & Information Management - Organizes engineering information so that requirements and technical knowledge are controlled, searchable, accessible, and usable by the engineering community.

Collaboration & Facilitation - Builds effective working relationships with Technical Authorities, SMEs, project teams, and global stakeholders and facilitates development and review of technical content.

Systems Thinking - Understands how engineering standards, project delivery processes, external requirements, and individual technical requirements interact across the engineering lifecycle.

Execution & Organization - Effectively manages multiple documents, stakeholders, reviews, deadlines, and approval workflows while maintaining document quality.

Continuous Improvement - Identifies opportunities to simplify, standardize, and improve engineering practices, documentation, knowledge management, and project delivery processes.

Role Focus

This position serves as an Engineer within the Engineering Technical Authority organization. Strong technical writing, document management, and information-management capabilities are important competencies of the role, but the position is not intended to function as a standalone technical writer.

The Engineer will help ETA capture and organize engineering knowledge, maintain the Engineering Design Library, improve Engineering Project Delivery processes, and enable Technical Authorities and SMEs to efficiently develop, maintain, and communicate engineering requirements across the global engineering organization.

Technical ownership and approval of discipline-specific engineering requirements remain with the designated Engineering Technical Authority or SME.