Principal/Senior Principal Validation Engineer

Genentech; North Carolina; On-site; USD 95,000 - 212,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech is implementing a state-of-the-art Holly Springs validation program for a high-speed PFS assembly and packaging environment. The Principal/Senior Principal Validation Engineer will establish the lifecycle validation strategy, write and approve essential protocols, and ensure alignment with FDA, ISO, and EU requirements.

You will lead cross-functional teams across Process Development, Operations, QA, Automation, and Maintenance to deliver a compliant, scalable product line.

Qualifications

• Bachelor or Master in chemical/biochemical engineering or related field with 5–11 years in drug product fill finish/packaging
• Strong knowledge of cGMPs and regulatory requirements in pharma/biotech
• Hands-on experience with IQ/OQ/PQ/PPQ and validation of assembly/packaging lines

Responsibilities

• Establish and own the Validation Master Plan for high-speed PFS lines and facilities
• Author/review PQ and PPQ protocols, sampling plans, and summary reports
• Lead validation studies for New Product Introductions and technology transfers
• Provide leadership for change controls, deviations, risk management, and regulatory compliance
• Mentor junior engineers and collaborate with multi-disciplinary teams across Development, Operations, QA, Automation and Maintenance
• Prepare and present validation program status for audits/regulatory inspections
• Support and lead equipment qualifications and capacity planning for a greenfield site

Skills

Validation expertise

Regulatory knowledge

cGMP experience

Project management

Cross-functional collaboration

Leadership/mentorship

Documentation writing

Audits/regulatory submissions

Education

BS/MS in chemical/biochemical engineering

Job description

The Position

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:

Reporting to the Head of Validation, the Principal/Senior Principal Validation Engineer serves as the primary technical expert for establishing and executing validation strategies across high-speed pre-filled syringe (PFS) assembly, labeling, traying, automated cartoning, case packing, and associated facilities and utilities.

In this strategic, high-impact role, you will define, execute, and maintain the lifecycle validation strategy (IQ/OQ/PQ/PPQ as applicable) for combination product assembly and packaging lines, supporting facilities, and utilities—particularly in support of a new greenfield facility setup. You will bridge technical engineering, quality assurance, automation, and regulatory affairs to ensure manufacturing assets achieve peak operational readiness and strictly align with global combination product expectations (FDA 21 CFR Part 4 / Part 820, ISO 11607, EU Annex 1/15).

• You will establish, maintain, and own the Validation Master Plan (VMP) for high-speed PFS assembly, packing lines, and associated facilities/utilities lines as applicable.
• You will author, review, and execute PQ and PPQ protocols, sampling plan and summary reports associated with assembly and packaging lines, supporting utilities and facilities.
• You will contribute expertise in project management, technical design, testing, qualification, recipe development and validation to ensure successful installation, qualification and validation of the assembly/pack and visual inspection program.
• You will provide oversight of validation change control management, deviation management, risk management for validated equipment, utilities, processes and facilities supporting assembly and packaging lines.
• You will review and approve change controls (CRs), engineering specifications, and impact assessments for existing equipment modifications. You will perform appropriate qualifications as needed for change controls including authoring any documentations, executions of studies and summary report to close change controls.
• You will provide technical leadership and mentorship to junior validation engineers, project teams, and external contractors.
• You will lead validation deliverables for New Product Introductions (NPI), capital expansions, and drug-device combination product technology transfers.
• You will collaborate seamlessly across multi-disciplinary teams, including Process Development, Operations, Quality Assurance, Automation Engineering, and Maintenance.
• You will incorporate new regulations into manufacturing processes and validation programs ensuring continued compliance.
• You will prepare, review and approve relevant sections of regulatory submissions.
• You will lead the presentation of the validation program and maintenance of the validated state during periodic audits and regulatory inspections.
• Support and lead other validation activities as needed for the success of the new green field site. Including any equipment qualifications, temperature mapping or partnering with contract organizations.

Who you are:

• You have a BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 5 -7 years (Principal) and 8 -11 years (Senior Principal) experience in drug product fill finish/packaging, Engineering, Manufacturing, or Technical Services.
• You have experience in the pharma/biotech industry.
• You have hands-on experience in the design, selection, installation, and validation of equipment used in assembly and packaging of autoinjectors or pen lines.
• You have knowledge of cGMPs or equivalent regulations, experience working in a regulated environment, and a strong understanding of the regulatory requirements.
• You have working knowledge of visual inspections, assembly, and packaging, equipment qualification in a regulated environment.
• You have experience in managing equipment and process related projects, including commissioning and qualification, performance qualifications, PPQs, new product introduction, and technology transfers.
• You have demonstrated experience in writing and reviewing SOPs, sampling plans, protocols and reports for traceability, and compliance.
• You have experience in performing and leading validation studies within the pharmaceutical and biotechnology industry.
• You have experience working collaboratively with cross-functional teams, including development, operations, quality assurance, automation engineering, and maintenance.
• You have experience in driving continuous improvement initiatives related to process, equipment, and quality systems.
• You have demonstrated project management skills.
• You have operational excellence and industrial engineering skills.
• You have professional level written and oral communication skills.

This role will require full onsite work at the project office before transition to the site offices once complete.

The expected salary range for this position in Holly Springs, NC is $95,000 - $176,000 (Principal) or $114,400 - $212,400 (Senior Principal). 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.

Relocation benefits are provided.

Link to Benefits

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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