Elevatebio
Validation Engineer I
Waltham, Massachusetts, United States
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odds of building a lasting career here
Thin sponsorship signal and lottery-bound (~15% per draw). A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
The bottom of this range ($15,000) is below the Level I prevailing wage of $89,149. An H-1B cannot be filed below the prevailing wage, so an offer at the floor of this band could not be sponsored as posted.
DOL prevailing wage, 2026-27 wage year · Industrial Engineers (17-2112) · Boston-Cambridge-Newton, MA-NH. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- ElevateBio is looking to hire a Validation Engineer I to join the Validation Engineering.
- Ensure deliverables meet the overall facility milestones
- Ensure discrepancies are resolved and closed out in a timely manner
Responsibilities
- Perform and support periodic assessment review and revalidation activities
- Support development and review of engineering lifecycle documents for new and existing equipment
- Maintain the Validation Master Plan, engineering lifecycle documents, and validation program SOPs
- Support validation activities related to tech transfer projects for all manufacturing suites
- Support site capital projects and other improvement projects
- Support and execute Change Controls to qualified facilities, equipment, and utilities
Requirements
- Bachelor's degree in engineering or related field and at least 5 years of experience, OR Master's degree with at least 3 years of related experience, OR PhD with at least 1 year of experience.
- Experience in cGMP facility/equipment start-up, commissioning, and qualification
- Strong understanding of ASTM E2500 standards for commissioning, validation, and lifecycle management of GMP equipment and systems and GxP laboratories
- Required experience with good documentation practices and cGMP standards
- Ability to work on multiple tasks simultaneously
- Ability to stand, walk, bend and stretch for extended period of time
- Ability to lift 15-20 lbs
- Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
Nice to have
- Experience in cGMP processes such upstream cell expansion, downstream purification, and fill finish.
- Viral vector & Cell/Gene Therapies experience is a plus
- Experience in using Kneat is a plus
Compensation
- This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law
This listing is sourced directly from Elevatebio's careers page and normalized into a canonical job model.