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. You must submit an online application to be considered for the position. The Company will accept applications on an ongoing basis until the position is filled.

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 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

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

• Certified Validation Professional (CVP) preferred

• Cert Pharma Industry Professional (CPIP) preferred

• GAMP 5 Training Certificate (ISPE) preferred

Let us learn about you! Apply today. You must submit an online application to be considered for any position with us. This position will be posted until filled.

Looking to make an IMPACT with your career?

When you are thinking about joining a new team, culture matters. At Schneider Electric, our values and behaviors are the foundation for creating a great culture to support business success. We believe that our IMPACT values – Inclusion, Mastery, Purpose, Action, Curiosity, Teamwork – starts with us. IMPACT is also your invitation to join Schneider Electric where you can contribute to turning sustainability ambition into actions, no matter what role you play. It is a call to connect your career with the ambition of achieving a more resilient, efficient, and sustainable world. We are looking for IMPACT Makers; exceptional people who turn sustainability ambitions into actions at the intersection of automation, electrification, and digitization. We celebrate IMPACT Makers and believe everyone has the potential to be one. Become an IMPACT Maker with Schneider Electric – apply today!

• €36 billion global revenue

• +13% organic growth

• 150 000+ employees in 100+ countries

• #1 on the Global 100 World’s most sustainable corporations

You must submit an online application to be considered for any position with us. This position will be posted until filled. Schneider Electric aspires to be the most inclusive and caring company in the world, by providing equitable opportunities to everyone, everywhere, and ensuring all employees feel uniquely valued and safe to contribute their best. We mirror the diversity of the communities in which we operate, and ‘inclusion’ is one of our core values. We believe our differences make us stronger as a company and as individuals and we are committed to championing inclusivity in everything we do. At Schneider Electric, we uphold the highest standards of ethics and compliance, and we believe that trust is a foundational value. Our Trust Charter is our Code of Conduct and demonstrates our commitment to ethics, safety, sustainability, quality and cybersecurity, underpinning every aspect of our business and our willingness to behave and respond respectfully and in good faith to all our stakeholders. You can find out more about our Trust Charter here Schneider Electric is an Equal Opportunity Employer. It is our policy to provide equal employment and advancement opportunities in the areas of recruiting, hiring, training, transferring, and promoting all qualified individuals regardless of race, religion, color, gender, disability, national origin, ancestry, age, military status, sexual orientation, marital status, or any other legally protected characteristic or conduct.