88-50101950 Principal Validation Engineer

Roche • Hillsboro, OR

7d • Hybrid

About The Position

Genentech, Inc. seeks a Principal Validation Engineer at its Hillsboro, OR location. Duties include authoring, reviewing, and approving validation master plans, validation and change control documentation (protocols, summary reports, etc.) for development and validation activities. The role provides technical and engineering expertise to support drug product manufacturing, process/product tech transfers, and new technology introduction projects. The Principal Validation Engineer will serve as the Site Sterilization Subject Matter Expert (SME), developing and managing sterilization processes, overseeing change management, technical assessments, protocol/summary reports, and field executions. They will implement sterilization strategies for aseptic filling lines, including Risk Assessments to ensure compliance with global regulatory standards. The position involves coordinating, managing, and performing initial and continuous process qualifications, and participating in the identification, evaluation, and implementation of new process technologies. The engineer will own and facilitate planned and unplanned events, conduct Root Cause Analysis, and serve as a risk management representative on cross-functional and multi-site teams. Responsibilities also include conducting investigations of atypical events and implementing corrective/preventive actions, minimizing potential contamination to product by identifying gaps and improving contamination control procedures, and improving filling line downtime through change management, technical and risk assessments, and continuous improvement. The role includes improving the technical skills of junior engineers and contractors on validation principles and equipment functionality. The Principal Validation Engineer will participate in FDA and global regulatory audits and pre-approval inspections, serving as an audit lead and representing/defending Validation/Engineering requests, and responding to 483 form queries. This position may telecommute up to 1 day per week.

Requirements

• Master’s degree, or foreign equivalent, in Pharmaceutical or Chemical Engineering or related field and 8 years of experience as a Validation Engineer or related position
• Alternative: Bachelor’s degree, or foreign equivalent, in Pharmaceutical or Chemical Engineering or related field and 10 years of progressive, post-baccalaureate experience as a Validation Engineer or related position
• 5 years of experience must include: Sterilization using steam, dry heat and Chemical decontamination
• Aseptic facility and drug product manufacturing operations
• Clean room technologies (ISO grade A, B and interventions) including media fill and air flow visualization needed to support sterile manufacturing process
• Equipment Qualification with family/grouping approaches
• Sterile Boundary including product path and sterile hold times
• Proven technical leadership capabilities and structured problem solving (Root Cause Analysis)
• Experience with Quality systems including Trackwise, Veeva, and ValGenesis

Responsibilities

• Author, review, & approve validation master plans, validation & change control documentation including protocols, summary reports etc., for development and validation activities.
• Provide technical and engineering expertise to support the drug product manufacturing process, as well as process/product tech transfers and/or new technologies introductory projects.
• Serve as Site Sterilization Subject Matter Expert (SME); develop and manage sterilization processes including overseeing change management, technical assessments, protocol/summary reports and field executions.
• Implement sterilizations strategies for aseptic filling lines along with Risk Assessments to ensure compliance with the current global regulatory standards.
• Coordinate, Manage, and Perform Initial and continuous process qualifications.
• Participate in the identification, evaluation, and implementation of new process technologies in alignment with business objectives and regulatory requirements.
• Own and facilitate planned and unplanned events, and Root Cause Analysis along with serving as a risk management representative on cross-functional and multi-site teams.
• Conduct investigations and atypical events, as well as resulting corrective or preventive action implementation.
• Minimize potential contamination to product by identifying gaps and improving existing site contamination control procedures.
• Improve filling line down time through change management and technical and risk assessments, and through continuous improvement processes.
• Improve technical skill for junior engineers and contractors on validation principles and equipment functionality to increase overall productivity, performance and to develop new SMEs.
• Participate in FDA and global regulatory audits and pre-approval inspection.
• Serve as audit lead and represent and defend Validation/Engineering requests, and respond to 483 form queries and concerns.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal