---
title: 'Engineer I, MSAT at ElevateBio'
canonical: 'https://feeny.ai/job/engineer-i-msat-elevatebio-pittsburgh-pennsylvania-jfqjce045csy'
type: 'job'
last_seen: '2026-09-04'
---

# Engineer I, MSAT at ElevateBio

- **Company:** ElevateBio
- **Location:** Pittsburgh Pennsylvania, United States
- **Posted:** 2026-09-01
- **Last confirmed live:** 2026-09-04
- **Apply:** https://elevate.bio/about/jobs/6173532004?gh_jid=6173532004

## 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

As a Process Engineer for Manufacturing Science and Technology (MSAT), you will provide process science support for GMP manufacturing, technology transfers, development studies, characterization, validation, and continuous improvement projects within a highly matrixed cross functional team for manufacturing programs. The primary responsibility is to the be Subject Matter Expert (SME) for manufacturing processes. Additionally, you will write product impact assessments, root-cause analysis reports, sampling plans, technical reports, and provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements.

Here’s What You’ll Do

- Represents MSAT on project teams as technical subject matter expert (SME) for drug product manufacturing.
- Working cross-functionally across Process Development, Manufacturing, Supply Chain, Regulatory Sciences and Quality to provide technical assessment for technology transfers and process changes in a cGMP environment.
- Work with external clients as a part of cross functional project team member to successfully tech transfer manufacturing process to cGMP environment.
- Authoring and reviewing technical documentation related to manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations, regulatory submissions, and product impact assessments.
- Provide on-call or on the floor technical SME support for troubleshooting issues during cGMP manufacturing.
- Assist in the root cause determined of process related deviations in a timely and conclusion manner. The Candidate will work with a cross functional team to resolve complex problems and deviations using experience and the efficient application of scientific methodology and technical reasoning. This position may execute experiments and perform data analysis to resolve specific deviation questions, prepares technical reports and occasionally proposes comprehensive process solutions and improvements.
- Support gap analyses and risk assessments to support the capital projects and tech transfers.
- Assist in execution of Process Validation activities including authoring protocols and reports.
- Assist in development of data-based process performance monitoring systems.
- Perform process data-driven deviation resolution and improvement projects.
- Identifies and proposes continuous process improvements to management. The candidate will execute and occasionally leads complex process and procedural changes to improve drug product manufacturing process performance, robustness, productivity, safety, and efficiency.
- Design studies, author protocols and reports, for process characterization and validation studies
- Participate in evaluation of new technology and process automation for introduction into GMP manufacturing
- Support implementation of projects at site level with Quality Assurance to ensure on-time creation and lifecycle management of MSAT systems and procedures required for the Quality Management System (technology transfer, comparability, process controls documentation, process performance review, etc.)

## Requirements

- BS/MS in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 5+/3+ years of relevant experience
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture, and process development
- Practical expertise with cGMP manufacturing and regulatory regulations and requirements.
- Drug manufacturing experience required. Use of LOVO, Sepax, Rotea, CliniMACs devices, automated fillers preferred.
- Understanding of process development, validation, and lifecycle management to support comparability studies, process validation, and licensure changes
- Highly experienced with leading investigations, writing, deviation reports, change controls, and corrective actions
- Ability to share complex principles of knowledge to others (team member, stakeholder, external, or inspection) along with strong technical writing abilities
- Experience working in cross functional teams to obtain project deliverables
- Knowledge of data management tools and statistical process controls
- Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus

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

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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