---
title: 'Validation Engineer I at ElevateBio'
canonical: 'https://feeny.ai/job/validation-engineer-i-elevatebio-waltham-f3fg51tn31g7'
type: 'job'
last_seen: '2026-10-16'
---

# Validation Engineer I at ElevateBio

- **Company:** ElevateBio
- **Location:** Waltham, MA
- **Posted:** 2026-10-08
- **Last confirmed live:** 2026-10-16
- **Apply:** https://elevate.bio/about/jobs/6220844004?gh_jid=6220844004

## Job description

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

## The Role

ElevateBio is looking to hire a Validation Engineer I to join the Validation Engineering. The Validation Engineer I will perform qualification activities for the manufacturing facility, utilities, equipment, and instruments. The Validation Engineer I will provide validation support for technical transfer, capital projects and ongoing validation improvement projects on site working with Facilities, Capital Projects Engineering, Process Engineering, Manufacturing, Quality Control and Quality Assurance (QA) teams.

Here’s What You’ll Do

- Independently perform validation activities including installation qualification, operational qualification, performance qualification for BaseCamp projects related to facility, utilities, equipment and instrument
- Generate protocols for tests, verification, and qualification for GxP assets, as well as reports to document execution
- Ensure deliverables meet the overall facility milestones
- Perform and support periodic assessment review and revalidation activities
- Ensure deliverables are executed per ElevateBio Validation Master Plan and other required SOPs
- Ensure discrepancies are resolved and closed out in a timely manner
- Develop testing templates and qualification protocols using paper and electronic validation systems (Kneat)
- Perform system impact assessments, risk assessments
- 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
- Promote engineering best practices, Elevate SOPs, and cGMP regulations
- Work with Quality Assurance to ensure all validation activities are in compliance
- 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
- 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
- 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 manage priorities, deliverables, and schedule milestones
- Strong interpersonal, verbal communication, and technical writing skills

Physical and Environment Requirements:

- 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.
- Ability to perform routine repetitive motions with use of arms, wrists and hands

The budgeted range for this position is $105,000 - $145,000. 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. ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

## About ElevateBio

## Company Overview
- **One-liner**: ElevateBio is a technology-driven contract development and manufacturing organization (CDMO) that powers the creation of genetic medicines by providing integrated gene editing, process development, and cGMP manufacturing capabilities.
- **Entity Type**: Private (Series D – raised $401M in November 2025; total capital raised ~$1.3B)
- **Headquarters**: Waltham, Massachusetts, United States
- **Founded**: 2017
- **Founders**: Not publicly available

## Core Business
- Primary industry: Biopharmaceutical CDMO (cell and gene therapy, gene editing, mRNA therapeutics)
- Target customers: Biopharmaceutical innovators (B2B, enterprise)
- Mission: “To be the world’s most indispensable advanced therapy technology company, changing how companies operate, how products are created, and how disease is treated.”

## Products & Services
- **Gene Editing Tools & Discovery Services**: One of the world’s largest toolboxes of gene editing technologies (e.g., CRISPR enzymes), enabling flexible editing and broad access to the genome. Includes discovery services to move from target to optimized therapeutic candidate.
- **Process Development**: Scalable, robust manufacturing process design from preclinical through commercial scale.
- **Manufacturing (cGMP)**: Viral vectors, cell therapies, mRNA therapeutics, and lipid nanoparticles (LNP). Multi-modality capabilities with 98% batch success rate. Automated cell therapy manufacturing platform.
- **Regulatory Support & Commercialization**: Navigate CMC regulatory strategy from IND through BLA.
- **Next-Generation Sequencing / Rapid Analytics**: In-house analytics for quality and characterization.

## Market Standing
- **Valuation/Market Cap**: Not disclosed (private company)
- **Key Metric**: Total funding ~$1.3 billion (as of Series D close in November 2025)
- **Notable Investors/Partners**: Novo Nordisk (multi-target R&D collaboration worth up to ~$1.9B), Amazon Web Services (generative AI for CRISPR discovery), Sartorius (automated cell therapy platform), University of Pittsburgh / Richard King Mellon Foundation ($100M grant for biomanufacturing facility)
- **Growth Signals**: CNBC Disruptor 50 in 2021, 2023, 2024, 2025; Fast Company’s 2024 Most Innovative Companies; Boston Globe Top Place to Work (2022, 2023); first genetic medicines manufacturer to achieve ICMC multi-modality certification; opened flagship purpose-built biomanufacturing facility in Waltham, MA; achieved 98% manufacturing batch success rate across cell therapy, viral vector, and mRNA batches.

## Competitive Advantages
- **Integrated Model**: Science, process development, manufacturing, and quality operate under one roof – no hand-offs between stages.
- **Continuous Technology Investment**: Automation, AI-assisted design, and process innovation embedded as a permanent operating principle to reduce costs and timelines.
- **Multi-Modality Expertise**: Covers viral vectors, cell therapies, mRNA, LNP delivery, and gene editing – enabling partners to switch modalities without restarting.
- **Proprietary Gene Editing Toolbox**: Acquired Life Edit Therapeutics, adding one of the largest collections of gene editing enzymes and patents.
- **Industry-Leading Quality**: ICMC certification across multiple modalities and 98% batch success rate exceed industry standards.

## Strategic Focus
- Expand gene editing capabilities and delivery technologies (e.g., LNP in vivo delivery for nuclease editing).
- Scale manufacturing capacity through new facilities (Waltham flagship, Pittsburgh site).
- Deepen collaborations with pharma (Novo Nordisk) and tech (AWS) to accelerate therapy development.
- Apply generative AI to broaden CRISPR discovery for complex monogenic and polygenic diseases.
- Establish manufacturing blueprints for novel modalities such as base-edited therapies.

## Why Work Here
- **Culture**: Described as a group of “explorers” passionate about constant discovery, new technology, and progress in life-transforming therapies.
- **Benefits**: Medical, vision, and dental covered at 90%; low deductible; employer-paid life insurance and disability; 401(k) with 4% match (no vesting); 12 weeks parental leave; competitive PTO; commuter reimbursement; monthly cell phone stipend; fitness reimbursement; access to wellness apps.
- **Development**: LinkedIn Learning access, Insights Discovery training, ongoing professional development and manager training.
- **Work Environment**: Roles primarily based in Waltham, MA (on-site for manufacturing and lab positions). Hybrid/remote not explicitly stated but likely limited for operational roles.
- **Recognition**: Boston Globe Top Place to Work; named to CNBC Disruptor 50 multiple years.

## Sources
1. [elevate.bio](https://elevate.bio/)
2. [elevate.bio/about](https://elevate.bio/about/)
3. [elevate.bio/about/careers](https://elevate.bio/about/careers/)
4. [elevate.bio/about/our-journey](https://elevate.bio/about/our-journey/)
5. [LinkedIn](https://www.linkedin.com/company/elevatebio)

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- [Associate Director, Commercial Operations](https://feeny.ai/job/associate-director-commercial-operations-elevatebio-waltham-r8n0qy392tf2) — Waltham, MA
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