Principal Validation Engineer, CVRM

F. Hoffmann-La Roche AG; Holly Springs (NC); On-site; USD 95,000 - 176,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Genentech in Holly Springs, North Carolina, is seeking a Principal Validation Engineer to lead validation activities for a new state-of-the-art manufacturing plant. You will manage qualification programs for sterilization, filling, and related equipment, while coordinating with cross-functional teams to meet regulatory requirements.

The role requires 8+ years in drug product development or manufacturing, strong project management, and hands-on experience with GMP-compliant validation activities.

Qualifications

• BS/MS in chemical, biochemical engineering or related field with 8+ years of experience in drug product development or manufacturing.
• Experience in pharma/biotech industry is required.
• Knowledge of cGMPs or equivalent regulations.
• Working knowledge of facilities, utilities, filling, packaging, and equipment qualification in a regulated environment; hands-on qualification experience with most sterile filling equipment and support systems.
• Demonstrated project management skills.
• Professional level written and oral communication skills.

Responsibilities

• Develop and manage detailed project plans, validation plans and timelines for validation activities.
• Author, execute and summarize qualifications for sterilization systems, cleaning systems and filling equipment.
• Prepare change control documentation and summaries for all activities.
• Support project manager ensuring new systems are implemented on time and within budget.
• Present and defend completed work during audits and Health Authority inspections.
• Procure and manage contractor support for outsourced validation and risk management assignments.
• Lead risk assessments and contribute to investigations and change control.
• Mentor junior engineers and maintain state-of-the-art technical expertise.

Skills

Project management

Validation engineering

Regulatory compliance

cGMP knowledge

Cross-functional collaboration

Leadership

Education

BS/MS in chemical/biochemical engineering

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 based on the primary location for this position of Holly Springs, North Carolina is $95,000 - $176,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Link toBenefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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