The Opportunity:

Lead and oversee packaging technical transfers, packaging-line and equipment qualification activities, and packaging lifecycle management for assigned commercial products and CMO sites. This includes transfer planning and execution; packaging process, component, equipment, and line-readiness assessments; qualification and validation strategy; ongoing performance monitoring; and implementation of post-approval packaging changes, process improvements, and supply-continuity initiatives throughout the product lifecycle.

The successful candidate will serve as the primary packaging technical person for assigned CMOs, partnering cross-functionally with Quality, Supply Chain, Regulatory, Manufacturing, and external partners to manage packaging performance, investigate issues, drive continuous improvement, and maintain a state of inspection readiness.

• Serve as the primary technical person for assigned commercial CMOs, providing day-to-day oversight of packaging operations, technical performance, and compliance.
• Assess CMO packaging-site capability, capacity, infrastructure, and readiness to support commercial demand and future product needs.
• Evaluate and define requirements for primary packaging components, packaging lines, inspection systems, serialization, automation, and other site-specific equipment.
• Manage packaging technical transfers, including transfer planning, site and line readiness, process implementation, execution support, and post-transfer monitoring.
• Manage packaging equipment and process qualification, validation, PPQ, and continued process verification (CPV) activities.
• Manage packaging lifecycle activities, including post-approval changes, component or equipment changes, line improvements, process optimization, and supply-continuity initiatives.
• Manage packaging-related deviations, complaints, nonconformances, investigations, root-cause analyses, CAPAs, and change controls.
• Partner with Quality, Supply Chain, Regulatory, and CMO teams to maintain cGMP compliance, drive continuous improvement, manage documentation, and prepare for audits and inspections.
• Support APQRs by authoring appropriate packaging sections.

Required Experience, Skills and Education:

• Bachelor's or master's degree in Packaging Engineering, Packaging Science, or a closely related engineering discipline.
• Approximately 6-8 years of relevant pharmaceutical, biotechnology, medical device, or similarly regulated industry experience.
• Demonstrated commercial packaging experience, including responsibility for packaging operations, packaging engineering, or technical support.
• Experience managing or providing technical oversight to external CMOs, contract packagers, or commercial packaging sites.
• Strong knowledge of primary packaging systems, packaging equipment, line qualification, validation, PPQ, and Continuous Process Verification (CPV).
• Working knowledge of cGMP requirements and quality systems, including deviations, CAPA, complaints, change control, and technical documentation.
• Demonstrated ability to assess packaging-site capability, capacity, equipment needs, and operational risks.
• Strong communication, technical writing, project-management, and cross-functional collaboration skills; willingness to travel to CMO sites as needed.

#LI-CT1 #LI-Hybrid

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Base Pay Salary Range

$143,000-$178,000 USD

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