Principal/Senior Principal Quality Engineer Validation (MedTech)

TL;DR

Principal/Senior Principal Quality Engineer Validation (MedTech): Performing quality oversight and validation of manufacturing processes, equipment, and GMP computerized systems for drug product and finished goods with an accent on qualification principles and health authority compliance. Focus on overseeing tech transfers, facility expansions, and the scale-up of digital technology adoption within production.

Location: Must be based in or able to relocate to Hillsboro, Oregon, USA

Salary: $93,000 - $209,300

Company

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

What you will do

• Apply qualification and validation principles to manufacturing processes, quality systems, and engineering design fundamentals.
• Perform quality oversight of equipment, facility utility systems, and GMP computerized systems.
• Review and approve qualification and validation documents.
• Oversee tech transfer, new facility expansions, and the adoption of digital technology.
• Lead sub-streams or participate in cross-functional project teams to solve complex problems.
• Serve as a best practices resource on highly significant quality policies and long-range goals.

Requirements

• Bachelor's degree (Master's preferred).
• 8 years of industry experience for Principal or 12 years for Senior Principal.
• Industry experience in technical or quality validation.
• In-depth specialist knowledge of quality validation disciplines.
• Location: Must be based in or able to relocate to Hillsboro, Oregon.

Nice to have

• Combination Product Manufacturing Experience (single-use autoinjector platforms).

Culture & Benefits

• Discretionary annual bonus based on individual and company performance.
• Relocation benefits available for this position.
• Comprehensive benefits package as detailed by the company.
• Commitment to equal opportunity and an inclusive work environment.