Sebela Pharmaceuticals Inc. · 1 day ago
Validation Engineer
Holbrook, MA
Full-time
Onsite
Mid Level
$33/hr - $43/hr
3+ years expSebela Pharmaceuticals is a U.S. pharmaceutical company specializing in Gastroenterology and Women’s Health. The Validation Engineer will implement the Holbrook site’s validation plan, create and execute qualification and validation documents, and ensure compliance with industry regulations.
MarketingMedical DevicePharmaceutical
Responsibilities
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
Qualification
Required
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
Preferred
Auto CAD experience preferred
Benefits
Competitive benefits package included.
Company
Sebela Pharmaceuticals Inc.
Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market-leading position in Gastroenterology and a focus on innovation in Women’s Health.
201-500 employees
H1B Sponsorship
Sebela Pharmaceuticals Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2022 (2)
Funding
Current Stage
Growth StageTotal Funding
unknown2016-01-01Private Equity
Leadership Team
Kelly Culwell
Chief Medical Officer and Head of Research and Development, Women's Health
Recent News
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2025-11-18
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