EMS Validation Engineering Lead jobs in United States
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Schneider Electric · 5 months ago

EMS Validation Engineering Lead

Schneider Electric is a global leader in energy management and automation, and they are seeking an EMS Validation Engineering Lead. This role involves ensuring the Environmental Monitoring System (EMS) deployment meets industry, regulatory, and customer requirements, while leading validation projects and supporting Life Science initiatives.

ElectronicsEnergyEnergy ManagementInformation TechnologyRenewable Energy
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Validation Project Lifecycle SME: Assume Subject Matter Expert (SME) role in the Development, execution, and management of validation protocols including Design Qualification (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Performance Qualification (PPQ) for the Schneider Electric EMS package
Documentation & Compliance: Develop and maintain comprehensive validation documentation such as Validation Master Plans (VMPs), risk assessments, SOPs, and validation summary reports. Ensure all documentation aligns with GMP, ISO 13485, 21 CFR Part 11, EU Annex 11/15, and internal QMS requirements. Collaborate with other Schneider Electric SME’s to define, maintain, and coordinate company standards and templates
Technical Design, Execution & Support: Design and support configuration of the Schneider Electric EMS, including control strategies, operator graphical interfaces, and implementation of control logic to meet client needs. Provide hands-on technical support during commissioning and qualification phases. Investigate and resolve deviations, discrepancies, and non-conformances. Support root cause analysis and implement corrective and preventive actions (CAPAs). Apply GAMP 5 principles and risk-based approaches to computerized system validation (CSV)
Customer & Project Coordination: Collaborate with cross-functional teams including project management, engineering, field startup, and client representatives. Participate in internal and external meetings, define validation scopes, and ensure alignment with project timelines and regulatory expectations. Support audits and inspections by presenting validation strategies and documentation
Continuous Improvement: Assume lead role in staying up to date with industry trends and advancements for both the Life Science Industry and the Schneider Electric technical offering. Identify opportunities to streamline validation processes, enhance documentation practices, and improve system reliability. Contribute to the development of best practices and internal standards
Business Development: Capability to work closely with account representatives and pre-construction for Life Science opportunities, providing technical guidance during the sales phase
Remote Deployment Support: Willingness and availability for travel to support remote meetings, internal planning and execution strategizing, and on-site activities throughout the project lifecycle

Qualification

GMP regulationsValidation methodologiesComputerized systems validationProject managementMicrosoft Office SuiteRegulatory requirementsTechnical writingCross-functional collaborationMulti-taskingRemote team coordinationAvailability for travelContinuous improvementBusiness developmentRoot cause analysisCorrective actionsCommunicationAttention to detailAdaptabilityProblem-solvingTeamwork

Required

10+ years' experience in validation, commissioning, or a quality role within a GMP regulated environment (pharma)
Four (4) Year engineering/technical degree in Pharmaceutical Manufacturing, Engineering, Science, or relevant field
Certifications required - EcoStruxure Building: WorkStation and System Design (MLL BLDPRDI0001027) and EcoStruxure Building: Technician (MLL BLDSERI0249000)
Deep understanding of GMP regulations, validation methodologies, and industry standards
Strong technical writing and documentation skills with attention to detail
Excellent communication and interpersonal skills for cross-functional collaboration and client interaction
Proficiency in Microsoft Office Suite; experience with MS Project and Visio is a plus
Highly adaptable, mobile and able to multi-task several project activities and support requests working in a proactive and reactive mode as necessary
Experience with validation of computerized systems
Understanding of regulatory requirements and guidelines (e.g. EU GMP Annex 11/15, 21 CFR Part 11, and GAMP 5)
Experience and comfort with managing work and schedules
Capability of supporting and coordinating with remote teams
Availability for travel up to 50% to support remote design and deployment

Preferred

Certified Quality Engineer (CQE)
Certified Validation Professional (CVP)
Cert Pharma Industry Professional (CPIP)
GAMP 5 Training Certificate (ISPE)

Benefits

Medical (with member reward points)
Dental
Vision
Basic life insurance
Benefit Bucks (credits to apply towards your benefits)
Flexible work arrangements
Paid family leaves
401(k) + match
Well-being and recognition (including service anniversary) programs
12 holidays per year
15 days of paid time off per year (pro-rated in the first year of employment based on start date)
Opportunity to purchase company stock (eligibility depends on start date)
Military leave benefits
Exceptional compensation package with bonus
Excellent benefits including Medical, Dental, Vision, Life Insurance, PTO, 401K with 6 % match, Stock purchase option, Tuition reimbursement, Wellness Program, company discounts, and much more!

Company

Schneider Electric

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Schneider Electric specializes in the digital transformation of energy management and automation.

H1B Sponsorship

Schneider Electric has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (150)
2024 (103)
2023 (108)
2022 (98)
2021 (115)
2020 (109)

Funding

Current Stage
Public Company
Total Funding
$4.08B
Key Investors
California State Water Resources Control BoardIdinvest Partners
2025-08-26Post Ipo Debt· $4.08B
2018-04-05Grant· $1.6M
2004-12-03Series Unknown

Leadership Team

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Deepak Sharma
President - Greater India zone, MD & CEO - Schneider Electric India Pvt. Ltd
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Jai Sharma
CFO Greater India Zone
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Company data provided by crunchbase