EMS Validation Engineering Lead

EMS Validation Engineering Lead

For this U.S. based position, the expected compensation range is $96,000 - $144,000 per year, which includes base pay and short-term incentive. The compensation range for this full-time position applies to candidates located within the United States. Our salary ranges are determined by reviewing roles of similar responsibility and level. Within the salary range, individual pay is determined by several factors including performance, knowledge, job-related skills, experience, and relevant education or training.

Schneider Electric also offers a comprehensive benefits package to support our employees, inclusive of medical (with member reward points), dental, vision, and 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), and military leave benefits.

As an EMS Validation Engineering Lead, you will play a lead role in ensuring Schneider Electric's (SE's) Environmental Monitoring System (EMS) deployment meets all industry, regulatory, and customer requirements. This position will be responsible for supporting all aspects of our Life Science projects, from our pre-construction and sales activities, through design and implementation, to our service and maintenance programs. This position requires a strong blend of project team leadership, technical expertise (industry and offering), documentation management, and customer-facing coordination.

Your contributions will be essential to both operational success and regulatory compliance, making you a key player in delivering a validated, audit-ready EMS solution for our clients.

• 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.

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…