Principal Validation Engineer, CVRM

Genentech; Holly Springs (MS); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech is building a state-of-the-art Holly Springs facility and seeks a Principal Validation Engineer to lead qualification activities for equipment and processes. You will drive Equipment Commissioning, Qualification, PV, CV, and tech transfer support in a fast-paced, highly accountable environment.

You will mentor junior staff, collaborate across site and network teams, and ensure compliance with regulatory expectations while advancing a culture of operational excellence and continuous

Qualifications

• Minimum of 8+ years in drug product Process R&D, Engineering, Manufacturing, or Technical Services.
• Pharma/biotech industry experience required.
• Knowledge of cGMP or equivalent regulations.
• Hands-on qualification experience with sterile filling equipment and support systems.
• Strong project management and cross-functional collaboration skills.

Responsibilities

• Develop and manage detailed project and validation plans and timelines.
• Author, execute and summarize qualifications for sterilization systems, cleaning systems, filling equipment and supporting equipment.
• Prepare change control documentation, including protocols and summary reports.
• Support project manager to ensure new systems are implemented within timelines and financial forecasts.
• Present and justify completed work during 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.
• Lead risk assessment sessions and contribute to PQ/CAPAs and product quality systems.

Skills

Project management

Regulatory compliance (cGMP)

Leadership / mentoring

Written and verbal communication

Cross-functional collaboration

Education

BS/MS in chemical/biochemical engineering or related field

Job description

Welcome to Holly Springs, North Carolina- home to Genentech's largest-ever investment with an ambitious goal to be a fully connected Plant of the Future. This is where next-generation technology, capability, digital connectivity and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. This will include Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products.

The facility's core is defined by innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant will not only meet today's demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines but is a strategic commitment to be scalable with this portfolio, which serves one of the largest patient populations in the world. This is a fast-paced, highly entrepreneurial environment with a high-level of accountability from the site team to launch operations in 2028.

Are you a problem-solver and change agent who thrives in a High-Performing Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to not only launch a state-of-the-art facility from the ground-up but to shape the culture of our organization for the next generation.

Join us in Holly Springs, where you won't just build a plant-you will build the future of medicine.

The Opportunity

Develops, implements and maintains validation status of the application equipment and manufacturing processes. Estimates qualifications needs, material needs and verifies pre requisite completions. Works independently within guidelines and policies, and receives minimal guidance. Acts as a resource for colleagues with less experience and provides functional guidance.

The Principal Validation Engineer will be accountable for performing activities such as Equipment Commissioning and Qualification, Cycle Development (CD), Performance Qualification (PQ) and Re-Qualification (RPQ) / Cleaning Validation (CV) and Process Validation (PV) in support of technology transfer and new technology introduction to the Hollysprings, North Carolina site.

What You'll Do

• Develop and manage the detailed project plans , validation plans and timelines for the execution of validation activities.
• Author, execute and summarize various qualifications for sterilization systems and equipment, cleaning system, filling equipment and supporting equipment (Autoclaves, Parts washer etc.).
• Prepare change control documentation, including protocols, summary reports, etc., for all activities.
• Support project manager ensuring new systems are implemented 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 to support integrating risk management into various Product Quality Systems (PQS) such as, Discrepancy Management, Change Control and CAPA.
• Lead and facilitate Risk Assessment sessions.
• Provide input into investigations and change control with potential impact to the site risk profile.
• Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements.
• Mentor more junior validation engineers and train individuals on practices and procedures.
• Closely collaborates with site and network organizations seamlessly
• Constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity
• Able to provide the leadership necessary to maintain a high performance culture

Who You Are

• BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 8+ years experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services is required.
• Experience in the pharma/biotech industry is required
• Knowledge of cGMPs or equivalent regulations
• Working knowledge of facilities, utilities, formulation, filling, and packaging, equipment qualification in a regulated environment is required . 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.
• Operational excellence and industrial engineering skills are a plus.
• Professional level written and oral communication skills required

Relocation benefits are available for this position.

The expected salary range for this position