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