Principal Validation Engineer, CVRM
About The Position
The Principal Validation Engineer develops, implements, and maintains validation status for application equipment and manufacturing processes at Genentech’s Holly Springs, North Carolina facility. The role works independently with minimal guidance and serves as a resource and functional guide for less experienced colleagues. The position supports technology transfer and new technology introduction through equipment commissioning and qualification, cycle development, performance qualification, requalification, cleaning validation, and process validation. It covers sterilization systems, manufacturing and filling equipment, cleaning systems, and supporting equipment. The engineer also contributes to risk management, change management, regulatory submissions, audits, and Health Authority inspections while collaborating with site and network organizations to support the launch of the facility’s manufacturing operations.
Requirements
- Bachelor’s or master’s degree in chemical engineering, biochemical engineering, or a related field, or equivalent 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, and 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 detailed project plans, validation plans, and timelines for validation activities.
- Author, execute, and summarize qualification activities for sterilization systems and 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 established 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 change management for new processes, equipment, utilities, and facilities.
- Prepare, review, and approve relevant sections of regulatory submissions.
- Represent risk management on cross-functional and multi-site teams, integrating it into Product Quality Systems such as Discrepancy Management, Change Control, and CAPA.
- Lead and facilitate risk assessment sessions.
- Provide input to investigations and change controls that could affect the site risk profile.
- Promote continuous learning and maintain technical expertise on industry advancements.
- Mentor junior validation engineers and train individuals on practices and procedures.
- Collaborate with site and network organizations.
- Identify creative and innovative solutions that support high productivity and quality.
- 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
