Principal Validation Engineer, CVRM
About The Position
The Principal Validation Engineer develops, implements, and maintains validation status for application equipment and manufacturing processes. Working independently with minimal guidance, the role estimates qualification and material needs, verifies prerequisite completion, and provides functional guidance to colleagues with less experience. The position supports technology transfer and new technology introduction at Genentech’s Holly Springs, North Carolina site. Accountabilities include equipment commissioning and qualification, cycle development, performance qualification, requalification, cleaning validation, and process validation. The engineer works with site and network organizations to support the launch of a highly automated drug-product manufacturing facility planned to begin operations in 2028. The role also contributes to risk management and product quality systems, supports regulatory submissions and health authority inspections, manages contractor support, and mentors other validation engineers. Relocation benefits are available. The expected salary range is $95,000–$176,000, with a discretionary annual bonus potentially available based on individual and Company performance.
Requirements
- Bachelor’s or master’s degree in chemical engineering, biochemical engineering, or a related field/experience.
- At least 8 years of experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services.
- Experience in the pharmaceutical or biotechnology industry.
- Knowledge of cGMPs or equivalent regulations.
- Working knowledge of facilities, utilities, formulation, filling, packaging, and equipment qualification in a regulated environment.
- Hands-on qualification experience with the majority of sterile filling equipment and support systems.
- Demonstrated project management skills.
- Ability to work with internal teams, partners, suppliers, and customers.
- Professional-level written and oral communication skills.
Nice To Haves
- Operational excellence and industrial engineering skills.
Responsibilities
- Develop and manage project plans, validation plans, and timelines for validation activities.
- Author, execute, and summarize qualifications for sterilization systems, equipment, cleaning systems, filling equipment, and supporting equipment such as autoclaves and parts washers.
- Prepare change control documentation, including protocols and summary reports.
- Support project managers in implementing new systems within predetermined timelines and financial forecasts.
- Present and provide rationale for completed work during periodic audits and Health Authority inspections.
- Procure and manage contractor support for outsourced validation and risk management assignments.
- Support the change management system for new processes, equipment, utilities, and facilities.
- Prepare, review, and approve relevant sections of regulatory submissions.
- Serve as a risk management representative on cross-functional and multi-site teams, integrating risk management into Product Quality Systems such as Discrepancy Management, Change Control, and CAPA.
- Lead and facilitate risk assessment sessions.
- Provide input into investigations and change controls that may affect the site risk profile.
- Maintain technical and industry expertise and foster continuous learning.
- Mentor junior validation engineers and train individuals on practices and procedures.
- Collaborate closely with site and network organizations.
- Identify creative and innovative solutions to maintain high productivity.
- Provide leadership to maintain a high-performance culture.
Benefits
- Relocation benefits are available.
- A discretionary annual bonus may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
