Senior Validation Engineer, Sterilization & Tech Transfer

Roche; Hillsboro (OR); On-site; USD 163,000 - 222,000; Full time

Benefits offered by this job

Annual bonus

Job summary

Genentech, Inc. in Hillsboro, OR, seeks a Principal Validation Engineer to lead validation master plans, change control, and related documentation for development and validation activities.

The role provides expert support for aseptic filling processes, sterilization strategies, and risk assessments aligned with current regulatory standards. The candidate will own process qualifications, drive continuous improvement, and participate in FDA/global audits, aiming to strengthen contamination

Qualifications

• Master’s degree or equivalent in Pharmaceutical or Chemical Engineering or related field.
• 8+ years of experience as a Validation Engineer or related position.
• 5 years of experience in sterilization/aseptic processing and GMP environments.

Responsibilities

• Author, review, and approve validation master plans, protocols, and summary reports.
• Support drug product manufacturing processes and technology transfers.
• Lead audits and respond to 483 forms and regulatory inquiries.
• Serve as Site Sterilization SME and oversee sterilization processes.
• Identify gaps, implement contamination control improvements, and minimize downtime.

Skills

Validation engineering

Sterilization

Process qualifications

Root cause analysis

Quality systems

Change management

Technical leadership

Audit readiness

Education

Master’s degree in Pharmaceutical/Chemical Engineering

Bachelor’s degree in Pharmaceutical/Chemical Engineering

Tools

TrackWise

Veeva

ValGenesis

Job description

Genentech, Inc. in Hillsboro, OR, seeks a Principal Validation Engineer to lead validation master plans, change control, and related documentation for development and validation activities.

The role provides expert support for aseptic filling processes, sterilization strategies, and risk assessments aligned with current regulatory standards. The candidate will own process qualifications, drive continuous improvement, and participate in FDA/global audits, aiming to strengthen contamination