Validation Engineer

États-Unis

Indianapolis, Indiana, United States

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

The Validation Engineer 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 will coordinate and execute qualification activities while collaborating with internal stakeholders and external vendors to support ongoing operations and capital projects.

KEY RESPONSIBILITIES

VALIDATION 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

QUALIFICATIONS

EDUCATION
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#LI-TH1

er will interface with our clients and be responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility, and process equipment.

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

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Validation Engineer

About Us

Job Description

KEY RESPONSIBILITIES

disciplines

QUALIFICATIONS

Company

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