Principal/Senior Principal Validation Engineer

Roche•Holly Springs, NC

1d•$95,000 - $212,400•Onsite

About 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.

Requirements

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

Responsibilities

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.
Establish, maintain, and own the Validation Master Plan (VMP) for high-speed PFS assembly, packing lines, and associated facilities/utilities lines as applicable.
Author, review, and execute PQ and PPQ protocols, sampling plan and summary reports associated with assembly and packaging lines, supporting utilities and facilities.
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.
Provide oversight of validation change control management, deviation management, risk management for validated equipment, utilities, processes and facilities supporting assembly and packaging lines.
Review and approve change controls (CRs), engineering specifications, and impact assessments for existing equipment modifications.
Perform appropriate qualifications as needed for change controls including authoring any documentations, executions of studies and summary report to close change controls.
Provide technical leadership and mentorship to junior validation engineers, project teams, and external contractors.
Lead validation deliverables for New Product Introductions (NPI), capital expansions, and drug-device combination product technology transfers.
Collaborate seamlessly across multi-disciplinary teams, including Process Development, Operations, Quality Assurance, Automation Engineering, and Maintenance.
Incorporate new regulations into manufacturing processes and validation programs ensuring continued compliance.
Prepare, review and approve relevant sections of regulatory submissions.
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.