Lead Validation Engineer – cGMP & CSV Expert

Barry-Wehmiller Companies Inc.; Boxborough (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Barry-Wehmiller Companies Inc. BW Design Group seeks a Validation Engineer to lead qualification activities for equipment, utilities, and processes in a regulated manufacturing setting. You will author protocols, support capital projects, and ensure ALCOA+ data integrity under cGMP requirements.

Ideal candidates bring 5+ years in validation within pharma/biotech or medical device environments, with GMP utilities and equipment experience, and strong technical writing and project management skills.

Qualifications

• Bachelor's degree in engineering or life sciences required.
• Minimum 5+ years of validation/engineering experience in a regulated environment.
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Responsibilities

• Author, review, and approve validation protocols and reports.
• Lead IQ/OQ/PQ execution for equipment, utilities, and systems.
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• CoT_job_summary_short
• JOB SUMMARY
• COMPANY NAME: Barry-Wehmiller Companies Inc.KEY POINTS: Validation SME, cGMP compliance, cross-functional leadership
• job_summary_short
• <p>Barry-Wehmiller Companies Inc. BW Design Group seeks a Validation Engineer to lead qualification activities for equipment, utilities, and processes in a regulated manufacturing setting. You will author protocols, support capital projects, and ensure ALCOA+ data integrity under cGMP requirements.</p><p>Ideal candidates bring 5+ years in validation within pharma/biotech or medical device environments, with GMP utilities and equipment experience, and strong technical writing and project management skills.</p>
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Skills

Technical writing

cGMP awareness

Project management

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in Engineering/Life Sciences

Master's degree preferred

Tools

Electronic validation systems

Job description

Barry-Wehmiller Companies Inc. BW Design Group seeks a Validation Engineer to lead qualification activities for equipment, utilities, and processes in a regulated manufacturing setting. You will author protocols, support capital projects, and ensure ALCOA+ data integrity under cGMP requirements.

Ideal candidates bring 5+ years in validation within pharma/biotech or medical device environments, with GMP utilities and equipment experience, and strong technical writing and project management skills.