EMS Validation Engineering Lead - 93862

Schneider Electric MA • Horsham, PA • 9h ago

DESCRIPTION/RESPONSIBILITIES: What will you do? 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.

Responsibilities Include

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.

Skills and Attributes Include

Deep understanding of GMP regulations, validation methodologies, and industry standards

Strong technical writing and documentation skills with attention to detail

Excellent communication and interpersonal s

kills 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

What's in it for me?

Career Growth and advancement opportunity

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!

Who will you report to? This position reports to the Operations Manager, Digital Buildings in Horsham, PA.

What skills and capabilities will make you successful?

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)

Certified Quality Engineer (CQE) preferred

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