Schneider Electric

EMS Validation Engineering Lead

Schneider Electric$96K — $144K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • 10+ years' experience in validation or quality roles in a GMP regulated environment (pharma)
  • Four-year engineering/technical degree in relevant fields such as Pharmaceutical Manufacturing or Engineering
  • Certifications in EcoStruxure Building design and technician roles required
  • Certified Quality Engineer (CQE) preferred
  • Experience with validation of computerized systems

Responsibilities

  • Lead development and management of validation protocols including DQ, FAT, SAT, IQ, OQ, PQ, and PPQ
  • Create and maintain validation documentation in line with regulatory standards
  • Design and configure the EMS according to client specifications, providing technical support during implementation
  • Collaborate with cross-functional teams to align validation efforts with project timelines
  • Drive continuous improvement by identifying opportunities to enhance processes and documentation
  • Provide technical guidance in pre-construction phases for business development
  • Support remote meetings and on-site activities, with willingness to travel up to 50%

Benefits

  • Career growth opportunities
  • Comprehensive medical, dental, and vision coverage
  • 401K with 6% company match
  • Tuition reimbursement and wellness programs
  • Stock purchase options and various company discounts
Full Job Description
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 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 BLDPRDI[redacted]) and EcoStruxure Building: Technician (MLL BLDSERI[redacted])
  • 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.

About Schneider Electric

Schneider Electric is a multinational corporation that specializes in energy management and automation solutions. The company was founded in 1836 and is headquartered in Rueil-Malmaison, France. Schneider Electric offers a wide range of products and services including electrical distribution, automation and control, and energy management. The company operates in over 100 countries and has a strong presence in the industrial and commercial sectors. Schneider Electric is committed to sustainability and has set ambitious targets to reduce its environmental impact. The company has received numerous awards for its sustainability efforts and is recognized as a leader in the industry.
Learn more about Schneider Electric
Size
166,025 employees
Industry
Founded
1836
NASDAQ

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