EMS Validation Engineering Lead - Schneider Electric : Job Details

EMS Validation Engineering Lead

Schneider Electric

Job Location : Horsham,PA, USA

Posted on : 2025-08-06T01:16:48Z

Job Description :

Join to apply for the EMS Validation Engineering Lead role at Schneider Electric.

As an EMS Validation Engineering Lead, you will play a key role in ensuring Schneider Electric's Environmental Monitoring System (EMS) deployment meets industry, regulatory, and customer requirements. This position involves supporting all phases of Life Science projects, from pre-construction and sales to design, implementation, and maintenance.

This role requires leadership, technical expertise, documentation management, and customer coordination. Your work will be crucial for operational success and regulatory compliance, delivering validated, audit-ready EMS solutions.

Responsibilities Include:

  • Validation Project Lifecycle SME: Manage validation protocols including DQ, FAT, SAT, IQ, OQ, PQ, and PPQ for the EMS package.
  • Documentation & Compliance: Develop validation documentation such as VMPs, risk assessments, SOPs, and reports, ensuring compliance with GMP, ISO 13485, 21 CFR Part 11, EU Annex 11/15, and QMS standards.
  • Technical Design & Support: Design EMS configurations, support commissioning and qualification, investigate deviations, and apply GAMP 5 principles.
  • Customer & Project Coordination: Collaborate with teams, participate in meetings, define validation scopes, and support audits.
  • Continuous Improvement: Stay updated on industry trends, streamline validation processes, and contribute to best practices.
  • Business Development & Remote Support: Support sales activities and travel up to 50% for project deployment.

    • Skills & Attributes:

    • Deep GMP validation knowledge
    • Strong documentation skills
    • Excellent communication
    • Proficiency in MS Office; MS Project and Visio a plus
    • Experience with validation of computerized systems
    • Understanding of EU GMP Annex 11/15, 21 CFR Part 11, GAMP 5
    • Ability to manage schedules and support remote teams
    • Willingness to travel up to 50%

    What's in it for you?

    • Career growth
    • Competitive compensation with bonus
    • Benefits including health, PTO, 401K, stock options, tuition reimbursement, and more

    Reporting Line: This position reports to the Operations Manager, Digital Buildings, Horsham, PA.

    Required Skills & Experience:

    • 10+ years in validation, commissioning, or quality roles within GMP environments
    • Four-year engineering/technical degree in relevant field
    • Certifications in EcoStruxure Building and other industry standards (preferred)

    Join us and make an impact!

    Apply online; position open until filled. Schneider Electric values diversity and inclusion, fostering a respectful, equitable workplace.

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