Full-Time

IT Professional

Quality Engineer, Validation

Posted on 9/17/2025

Deadline 10/1/25
Roche

Roche

1-10 employees

Global pharmaceuticals and diagnostics company

No salary listed

Indianapolis, IN, USA + 1 more

More locations: Mississauga, ON, Canada

In Person

Relocation is not eligible for this position.

Category
QA & Testing (1)
Required Skills
Agile
Software Testing
JIRA
SCRUM
Requirements
  • Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field
  • 3–5 years of experience in Quality Engineering within GxP-regulated environments (e.g., pharma, biotech, MedTech)
  • Strong regulatory knowledge, including FDA (CFR 21 Part 11), Annex 11, EU GMP Annex 1, MHRA (Data Integrity), and GxP practices
  • Good understanding of cloud-based platforms (i.e., SaaS, PaaS), EDMS (e.g., Veeva), ALM tools (e.g., JIRA, RETINA)
  • Expertise in system and data risk assessment
  • Understanding of Agile methodologies (e.g., SAFe, Scrum)
  • Effective communicator with excellent verbal and written proficiency in English
  • Basic understanding of software testing methodologies and associated processes and practices
Responsibilities
  • Identify process gaps and inefficiencies within testing, validation, and delivery processes, propose improvements, and champion quality engineering best practices to guide and mentor the product team
  • Review or ensure the creation of deliverables from Test Managers and Validation Leads for GxP-relevant systems, upholding an oversight role while maintaining segregation of duties
  • Evaluate and prioritize automation opportunities in testing and validation, collaborate with Test Automation Experts (TAEs) to implement solutions and Proof of Concepts
  • Foster a culture of continuous improvement by identifying enhancements in the SDLC processes through feedback, analysis, and applying best practices, including performing maturity assessments
  • Ensure validated systems remain audit-ready by managing IT controls such as change/configuration management, access/security, audit trails, and backups, while leading periodic system reviews
  • Lead quality investigations by driving deviation investigations, conducting root cause analyses, defining CAPAs, and acting as a CSV subject matter expert during audits and inspections
  • Champion compliance by safeguarding system validation and alignment with company procedures, maintaining readiness for internal and external audits

Roche is a global leader in pharmaceuticals and diagnostics. It develops medicines and diagnostic tools that help detect, monitor, and treat diseases, using research and biotechnology to drive new therapies and tests. Roche combines drug development with in-house diagnostic products to support personalized medicine, where treatments are tailored to individual patients based on test results. Its approach differs from many peers by integrating drug discovery with diagnostic capabilities and by expanding its research through strategic acquisitions (like Genentech) to strengthen its biotechnology and R&D capabilities. The company’s goal is to improve patient outcomes and healthcare worldwide by delivering reliable medicines, accurate diagnostic tests, and data-driven care.

Company Size

1-10

Company Stage

IPO

Headquarters

Basel, Switzerland

Founded

1896

Simplify Jobs

Simplify's Take

What believers are saying

  • CT-388 targets double-digit share in obesity market alongside Novo Nordisk and Lilly.
  • PathAI $750M acquisition scales AI digital pathology globally by late 2026.
  • Elecsys pTau217 Alzheimer's blood test launches in CE markets from July 2026.

What critics are saying

  • Rituxan patent expiry lets Sandoz biosimilars slash 40% lymphoma share in 6-12 months.
  • Swiss franc 12% rise compresses US 55% revenues as hedges expire in 6-18 months.
  • US IRA forces 60-80% discounts on Herceptin, Avastin from 2028, cutting $4B cashflow.

What makes Roche unique

  • Roche integrates pharmaceuticals and diagnostics via 1991 PCR acquisition from Cetus.
  • 1990 Genentech majority stake pioneered oncology antibodies like Herceptin and Rituxan.
  • Personalized healthcare strategy couples diagnostics to targeted therapies since 2009 full acquisition.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Performance Bonus

Company News

Dealroom.co
Apr 16th, 2026
SAGA company information, funding & investors

SAGA, providing cancer companion diagnostic testing of tissue and non-invasive monitoring of circulating tumor dna (ctdna). Here you'll find information about their funding, investors and team.

Yahoo Finance
Apr 13th, 2026
Roche receives CE mark for Elecsys NfL blood test to detect neuroinflammation in multiple sclerosis

Roche has received CE mark approval for its Elecsys Neurofilament Light Chain blood test to detect neuroinflammation in adults with relapsing remitting multiple sclerosis. The test measures NfL, a protein released during nerve cell injury, providing insight into neuroaxonal damage associated with the disease. Multiple sclerosis affects over 2.9 million people worldwide. Whilst early and regular monitoring is critical, patients often struggle to access routine MRI scans. The minimally invasive blood test offers a more accessible alternative, complementing clinical assessments and potentially enabling earlier intervention. The test runs on Roche's widely available cobas instruments, delivering standardised results and requiring only a simple blood sample. This reduces the need for patients to travel to specialist centres, making frequent monitoring more practical where traditional testing faces geographic, financial or logistical barriers.

Bizwatch
Apr 12th, 2026
Roche invests $20M in degrader-antibody conjugate platform via C4 Therapeutics deal worth up to $1B

Roche has partnered with C4 Therapeutics to develop degrader-antibody conjugates (DACs), marking a $20 million upfront payment with potential milestone payments exceeding $1 billion. The collaboration targets cancer therapeutics using C4's Torpedo platform. DACs represent a next-generation approach to antibody-drug conjugates (ADCs). Whilst ADCs attach cytotoxic drugs to antibodies, DACs use targeted protein degradation payloads to selectively eliminate specific proteins within cancer cells, potentially reducing toxicity and drug resistance whilst accessing previously difficult targets. Amongst Korean listed companies, Orum Therapeutics leads DAC development, having licensed ORM-6151 to Bristol Myers Squibb in 2023. Y-Biologics partnered with Ubix Therapeutics, whilst Oscotec is developing three DAC pipelines through subsidiary Genosco, targeting technology transfers after 2028.

Yahoo Finance
Mar 30th, 2026
Roche gets FDA clearance for cobas c703 and ISE neo lab testing units with 2,000 tests per hour

Roche has received FDA 510(k) clearance for its cobas c703 and cobas ISE neo analytical units, designed to enhance laboratory efficiency through increased automation and testing capacity. The units are part of Roche's cobas pro integrated solutions platform. The cobas c703 delivers up to 2,000 tests per hour with 70 reagent positions, doubling clinical chemistry throughput whilst reducing reagent reloads. The cobas ISE neo provides up to 1,800 tests per hour with automated maintenance, reducing hands-on time and plastic waste compared to previous systems. Both units feature monthly operator maintenance to improve uptime and help laboratories address staffing shortages and growing test volumes. Roche has over 4,000 cobas analysers installed across the United States.

Yahoo Finance
Mar 30th, 2026
Roche launches cobas MPX-E assay, 4-in-1 donor screening test for HIV, HCV, HBV and HEV

Roche has launched the cobas MPX-E assay, a four-in-one donor screening test that simultaneously detects HIV, Hepatitis C, B and E viruses. The test is now available in countries accepting the CE mark. The assay consolidates detection of four major viral targets into a single workflow, improving laboratory efficiency and reducing costs. It features dual-target detection for HIV-1 and enhanced sensitivity for Hepatitis E, which causes an estimated 20 million infections and 70,000 deaths annually worldwide. The test runs on Roche's fully automated cobas x800 systems, which process over 10 million tests monthly across laboratories globally. The ready-to-load reagents enable up to eight hours of walk-away time. The nucleic acid testing blood screening market is valued at approximately 800 million Swiss francs globally, with an expected annual growth rate of 2% through 2029.

INACTIVE