Embedded System Validation Engineer Jobs in Lexington, MA

About Us:

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.

 

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

 

Job Description:

Job Summary

The Validation Engineer III will serve as a key member of the validation team, providing expert-level support to ensure facility equipment, utilities, processes, instrumentation, and computerized systems are qualified and maintained in a validated state in compliance with applicable regulatory requirements. This role functions as a Validation Subject Matter Expert (SME) responsible for leading validation activities, authoring protocols and reports, and providing technical guidance to cross-functional teams. The Validation Engineer III will coordinate and execute qualification activities while collaborating with internal stakeholders and external vendors to support ongoing operations and capital projects.

Key ResponsibilitiesValidation Documentation & Execution

• Author, review, and approve validation protocols, reports, and associated documentation including acceptance criteria development

• Establish, revise, and maintain validation master plans, procedures, and lifecycle documentation for qualification of equipment, systems, and processes in accordance with cGMP requirements

• Execute and oversee IQ/OQ/PQ protocols for equipment, utilities, and systems

• Review and complete documentation in accordance with cGMP, ALCOA+ principles, and data integrity requirements

Project & Program Management

• Lead and manage validation-related project activities including scheduling, resource coordination, protocol execution, and report review

• Manage external vendors and contractors performing qualification activities

• Serve as a key member of project teams for design, procurement, installation, and commissioning of new equipment and facility expansion projects

• Develop and maintain validation project timelines and deliverables

Compliance & Change Control

• Review proposed changes to validated systems and provide impact assessments

• Identify validation requirements necessary to maintain systems in a validated state following change implementation

• Manage periodic requalification activities to ensure equipment, utilities, and processes remain compliant

• Support equipment and building monitoring systems compliance and updates

Technical Expertise

• Serve as Subject Matter Expert (SME) in one or more of the following disciplines:

  • Process Mapping

  • Quality Management (Quality Risk Assessments; Change Controls; Deviations; CAPA; Documentation)

  • Equipment qualification (autoclaves, controlled temperature units, filling equipment)

  • Cleaning validation Aseptic process simulation (media fills)

  • Computer system validation (CSV)

  • Process validation Utility qualification (WFI, purified water, clean steam, HVAC)

  • Environmental monitoring systems

• Provide technical guidance and troubleshooting support for equipment and system failures

• Deliver training on validation program elements to junior validation personnel

Quality Systems Support

• Author and support equipment and process-related deviation investigations and CAPA activities

• Perform and support risk assessments (FMEA, etc.) and data integrity assessments

• Support internal audits and regulatory agency inspections

• Ensure all work is performed in accordance with SOPs, cGMPs, quality standards, and safety procedures

QualificationsEducation

• Bachelor's degree in Engineering, Life Sciences, or related scientific discipline required

• Master's degree (MS/MSc) preferred

Experience

• Minimum 5+ years of professional experience in validation, engineering, or operations within a regulated environment

• Minimum 4+ years of direct experience in a cGMP pharmaceutical, biotechnology, or medical device manufacturing environment

• Demonstrated expertise as a Subject Matter Expert (SME) in one or more validation disciplines

• Experience with GMP utilities (WFI, purified water, clean steam, compressed gases, HVAC) and manufacturing equipment

• Experience supporting regulatory inspections (FDA, EMA, or equivalent) preferred

• Capital project experience including equipment design, selection, and commissioning preferred

Skills & Competencies

• Strong technical writing skills with ability to author clear, compliant documentation

• Solid working knowledge of cGMP regulations, FDA guidance documents, and industry standards (ISPE, PDA, GAMP)

• Understanding of GDP requirements and ALCOA+ data integrity principles

• Excellent communication and interpersonal skills with ability to interface across all organizational levels

• Strong project management and organizational skills

• Ability to work independently with minimal supervision while also functioning effectively in a team environment

• Self-motivated with demonstrated initiative and problem-solving abilities

• Proficiency in Microsoft Office Suite; experience with electronic validation systems a plus

Working Conditions

• On-site presence required; may involve work in manufacturing, laboratory, and utility areas

• Ability to gown into cleanroom environments as required

• Occasional flexibility in schedule and travel may be needed to support project timelines or production schedules

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At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work-therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.

Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.

 

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

Company:

Design Group