Roche · 1 month ago
Validation Engineer/Senior Validation Engineer, Quality Control
Hillsboro
Full-time
Onsite
Mid, Senior Level
$68K/yr - $127K/yr
1+ years expRoche is a leading pharmaceutical company, and they are seeking a Senior Validation Engineer to join their Quality Control team. This role involves qualifying equipment and software, maintaining validation history, and ensuring compliance in the manufacturing process of life-saving medicines.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
You will author, review and complete equipment qualification / computer system qualification protocols and generate equipment lifecycle documents (i.e. User Requirements Specifications, Data Integrity Assessments, Test Protocols, Operational and Administration Procedures, etc.) using Roche’s electronic validation system (ValGenesis)
You will participate on analytical transfer teams with focus on equipment qualification. Facilitate / complete equipment gap assessments, contribute to comprehensive transfer plans, complete transfer activities related to equipment qualification in collaboration with QC Operations, Quality Validation and other Analytical Specialists from the donating and receiving sites
You will define, establish, standardize, and complete and/or improve practices for maintaining the validated state of QC equipment (analytical, microbial and bioassay) throughout its lifecycle through periodic reviews, monitoring, and re-qualification
You will serve as a site representative on network-wide validation teams formed to discuss emerging issues through resolution, and improve and standardize qualification of platform equipment. The information discussed at these teams are routinely submitted via a sponsor to decision making bodies within the relevant/impacted functional areas including HTO. As a representative, you will be the voice for HTO and are accountable for ensuring information / decisions are disseminated to and from these teams
You will participate in Quality Control investigations related to QC equipment issues and completing data driven impact assessments and actions
You will collaborate with key partners to identify and complete Corrective and Preventive Action actions
You will author, review, and/or approve various business process & compliance related documents such as, standard operating procedures, work instructions, monitoring protocols, monitoring reports, gap assessments, and risk assessments related to the supported methods
Qualification
Required
You hold a Bachelor's of Science degree with 1-3 years (Validation Engineer level) or 4-7 years (Senior Validation Engineer level) of dynamic experience in the pharmaceutical or scientific industry
You have significant experience working in a cGMP or similarly regulated environment
You possess a deep understanding of equipment and/or computer system validation practices, regulations, and industry guidelines and consistently apply this understanding when performing your tasks
You are a strong problem-solver and have the proven ability to solve and resolve analytical instrument issues
You have the judgment / discretion to advance matters of significance, ensuring efficient testing operations and regulatory compliance
You possess outstanding social skills and strong written and verbal communication skills. You use these skills to build effective multi-functional teams and commit to timely informed decisions and completion of simple to moderate actions from others
You have a passion and ability for mentoring and encouraging others and are able to build/maintain effective multi-functional teams without direct management responsibilities
You will be working on site in a flexible open space work environment with random visits to a QC laboratory environment that requires laboratory gowning (lab coat, goggles, gloves)
You will work on/interact with analytical instruments and computerized systems/screens for long periods of time (6-8 hours)
You may be required to lift up to 25lbs
You may have to work with hazardous materials and chemicals
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
Relocation benefits are available for this position.
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
2026-01-09
2026-01-07
Company data provided by crunchbase