Roche · 23 hours ago
Associate Engineer/Engineer Manufacturing Engineer (Cell & Gene Therapy)
Hillsboro
Full-time
Onsite
Entry, Mid Level
$61K/yr - $113K/yr
1+ years expRoche is a leading company in the field of individualized therapies, and they are seeking an Associate Engineer/Engineer for their Manufacturing team in Hillsboro. This role involves supporting technology transfers and production of innovative cell and gene therapies, collaborating with various teams to establish manufacturing processes, and ensuring quality and safety standards are met.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
Own the development of batch-related documentation, including manufacturing batch records, SOPs, training materials, and associated forms
Collaborate with compliance and quality members to assess process risks and establish controls for product safety and efficacy
Lead end-to-end manufacturing operations for clinical and/or commercial products, encompassing solutions/buffer preparation, cell culture, gene editing, cellular isolations, guided stem cell differentiation, filtration, chromatography, formulation, fill-finish, and aseptic operations
Drive process improvements and efficiencies using LEAN methodologies, implementing standard work and maximizing productivity
Utilize single-use technology, new analytical techniques, and digital manufacturing systems to optimize bioprocess facility capacity
Qualification
Required
You possess a Bachelor's degree and 1-2 years (for Associate Engineer level) or 4 years (for Engineer level) of relevant cell and/or gene therapy industry experience
You have experience authoring and reviewing GMP documents such as SOPs, Batch Records, Learning Curriculum, Development Protocols and Qualification Documents
You have experience working in a commercial or clinical GMP environment
You have experience with technology transfers
You have experience as a trainer or leading a small team
You are available to work off-shift hours to support business needs
Must be able to work all shifts (1st, 2nd, or 3rd, weekends, holidays, 12 or 10 hours), require overtime as needed, and stand for extended periods
Preferred
Bachelor's degree in cellular or molecular biology or engineering
Experience driving continuous improvement / using LEAN methodologies
Experience with data analysis software, ERP systems, Manufacturing Execution Systems, and quality management systems
Benchwork/lab work experience (working in biosafety cabinets, pipetting, PCR, purification, open and closed cell culture, aseptic technique, etc)
Experience managing deviations in a GMP environment or supporting impact assessments
Experience with New Product Introductions
Change Control
Knowledge of Health Authority requirements
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
Relocation benefits are approved for this posting.
Company
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
10001+ employees
H1B Sponsorship
Roche 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 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
Alan Hippe
Member of the Executive Board - Group CFO
Christine Bakan
Global Head and VP of Software and Bioinformatics, Next Generation Sequencing
Recent News
2026-01-07
2026-01-07
Company data provided by crunchbase