Principal/Senior Principal Process Engineer (Aseptic Operations)

TL;DR

Principal/Senior Principal Process Engineer (Aseptic Operations): Leading and supporting product tech transfers to the Hillsboro Technical Operations site with an accent on aseptic filling, component preparation, and process validation. Focus on ensuring regulatory compliance, managing complex equipment qualification projects, and mentoring engineering staff to maintain high-quality manufacturing standards.

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

Salary: $114,380 – $256,750 (depending on level and experience)

Company

hirify.global, a member of the Roche group, is a pioneer in the biotechnology industry dedicated to discovering and developing medicines for serious and life-threatening diseases.

What you will do

• Lead and facilitate technology transfers and process validation activities for drug products.
• Manage project timelines, protocol development, execution, and technical report writing.
• Support equipment qualification and commissioning for new manufacturing technologies.
• Provide technical rationale for regulatory submissions and represent the site during audits and inspections.
• Mentor and train junior engineers while fostering a culture of continuous learning.
• Collaborate with cross-functional teams including Manufacturing, Quality Assurance, and Engineering Science & Technology.

Requirements

• BS/MS in Engineering, Pharmaceutical Sciences, or related field.
• Minimum 8 years (Principal) or 12 years (Senior Principal) of relevant experience in the pharma/biotech industry.
• In-depth knowledge of cGMP regulations and regulatory requirements (FDA, EMA).
• Strong expertise in formulation, component preparation, and aseptic filling process development.
• Proficiency in data analysis and statistical tools for process monitoring.
• Ability to work onsite in Hillsboro, Oregon.

Culture & Benefits

• Competitive salary with discretionary annual bonus based on performance.
• Comprehensive benefits package including health, retirement, and insurance plans.
• Relocation assistance provided for eligible candidates.
• Opportunity to work in a world-class manufacturing facility with a focus on groundbreaking science.
• Commitment to diversity, inclusion, and equal opportunity employment.