Validation Engineer
$85,500-$96,750
•
Boston, MA
• Direct Hire
• Job Number:268317
• Posted:1/23/2026
80K-100K plus bonus
Bachelor’s degree or higher in Engineering, Life Sciences or related discipline.
3+ years relevant FDA regulated industry/validation experience or an equivalent amount of validation experience.
Solid experience supporting/driving qualification and validation projects related to the pharmaceutical industry.
Exceptional technical writing, review and analytical skills.
Knowledge of good documentation practices and cGMPs.
Must have strong ability to organize and manage multiple tasks in a fast-paced environment.
Exceptional verbal and written communication skills.
Auto CAD experience strongly preferred.
Requirements
Manage qualification and validation projects from planning stages to completion.
Create and execute Equipment Qualification Protocols (IQ/OQ/PQ).
Create and execute cleaning and process validation protocols.
Create and execute Computerized Systems validation protocols.
Responsible for the development of documentation to support computer validation such as User/Functional Requirements specifications, Design Specifications and Risk Assessments.
Troubleshoot validation issues to maintain the quality of the product and maximize efficiency.
Support establishing resolutions and impact assessment for validation issues.
Perform batch record and SOP revisions.
Draft Incident and Deviation reports.
Complete cGMP documentation and validation protocols accurately.
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