Senior Quality Assurance Engineer (Biopharmaceutical)

TL;DR

Senior Quality Assurance Engineer (Biopharmaceutical): Ensuring the quality and compliance of novel biopharmaceutical technologies through site qualification and system validation with an accent on Computer System Validation (CSV) and cGMP compliance. Focus on providing technical oversight for production start-up, managing risk logs, and defending validation programs during regulatory audits.

Location: On-site in Hillsboro, Oregon, USA

Salary: $93,000 - $172,800

Company

hirify.global, a member of the Roche group and pioneer of the biotechnology industry, focuses on discovering and developing medicines for serious and life-threatening diseases.

What you will do

• Provide day-to-day Quality Oversight for site qualification, equipment validation, and Computer System Validation (CSV) during production start-up.
• Review and approve essential lifecycle documentation, including Validation Master Plans, User Requirements, Protocols, and Summary Reports.
• Collaborate during build and deploy phases to support user requirement definitions and design specifications for laboratory and production equipment.
• Maintain constant inspection readiness and directly defend the validation program during regulatory audits.
• Manage the validation risk log and provide technical quality assessments for engineering modifications, process changes, and CAPAs.
• Partner with global corporate teams to implement validation best practices and benchmark against industry standards.

Requirements

• Bachelor's degree in Engineering or Life Sciences with 8+ years of pharma experience, or a Master's degree with 6+ years of experience.
• Must be based in or able to work on-site in Hillsboro, Oregon.
• Sound knowledge of engineering principles, qualification concepts, and US/EU cGMPs.
• Technical familiarity with automation and execution systems such as Delta V/SCADA, Syncade MES, BAS, EBR, and Pi Data historian.
• Strong understanding of Risk Assessment Methodologies (PHA, FMEA, FTA).
• Willingness to travel up to 30% to other sites.

Nice to have

• Cell therapy experience.

Culture & Benefits

• Comprehensive benefits package.
• Discretionary annual bonus based on individual and company performance.
• Opportunity to work with a dedicated cross-functional team in a cutting-edge biopharmaceutical environment.
• Commitment to merit-based growth and equal opportunity employment.