Principal Validation Engineer, Pharma Packaging Automation

Genentech

Holly Springs (NC)

On-site

USD 95,000 - 212,000

Full time

14 days+

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Benefits offered by this job

Relocation benefits

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Job summary

Genentech in Holly Springs, NC is hiring a Principal/Senior Principal Validation Engineer to lead validation strategies for high-speed assembly and packaging lines, supporting a greenfield site. You will own IQ/OQ/PQ/PPQ programs and the Validation Master Plan to ensure regulatory alignment.

The role requires collaboration across Development, QA, Automation and Maintenance, mentoring junior engineers, and guiding NPI, capital expansions, and technology transfers toward on-time startup.

Qualifications

BS/MS in chemical, biochemical engineering or related field.
5–7 years (Principal) or 8–11 years (Senior Principal) in drug product fill finish/packaging or related.
Experience with cGMPs in regulated environments.

Responsibilities

Define, execute and maintain the lifecycle validation strategy (IQ/OQ/PQ/PPQ) for assembly, labeling, and packaging lines.
Author and review PQ/PPQ protocols, sampling plans and reports.
Provide technical leadership and mentorship to junior engineers and contractors.
Lead validation deliverables for NPI, capital expansions, and tech transfers.
Collaborate with Process Development, Operations, QA, Automation, and Maintenance.

Skills

Validation strategy

IQ/OQ/PQ/PPQ

VMP ownership

Change control

Risk management

Project leadership

Education

BS/MS in chemical/biochemical engineering

Job description

The role requires collaboration across Development, QA, Automation and Maintenance, mentoring junior engineers, and guiding NPI, capital expansions, and technology transfers toward on-time startup.

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