CQV Engineer — Optima Filling Systems

We are seeking an experienced CQV Engineer with specialized hands-on expertise in Mars and Optima filling systems to support commissioning, qualification, and remediation activities for a pharmaceutical filling line. The successful candidate will play a key role in the Filling Line 17 remediation program, supporting IQ/OQ/PQ, SIP qualification, smoke studies, environmental monitoring, and disinfection qualification activities.

This role will work closely with the broader CQV, CSV, AI, Engineering, and Quality teams, as well as a parallel Norden-focused CQV workstream, to deliver qualification activities within an accelerated timeline and in alignment with GMP and FDA

Develop, review, and execute commissioning and qualification protocols, including IQ, OQ, and PQ, for Mars and Optima filling equipment.
Provide hands-on technical support for Mars and Optima filling/packaging systems throughout commissioning and qualification activities.
Support SIP cycle development, optimization, and qualification for applicable filling technologies.
Evaluate SIP qualification activities in consideration of the product's moisture-sensitive critical quality attributes (CQAs).
Develop and execute smoke studies to demonstrate appropriate airflow patterns and aseptic processing conditions.
Support environmental monitoring process qualification activities and associated documentation.
Develop, review, and execute disinfection qualification protocols.
Review equipment specifications, URS/design documentation, FAT/SAT records, vendor documentation, and existing site qualification standards.
Ensure qualification protocols and test activities are aligned with site procedures, GMP requirements, and approved specifications.
Identify and document qualification gaps, deviations, and discrepancies and support appropriate resolution.
Collaborate with the Norden-focused CQV Engineer and broader CSV/AI/CQV teams on interdependent qualification activities.
Coordinate with equipment vendors, Engineering, Manufacturing, Microbiology, Quality Assurance, and other stakeholders.
Execute qualification activities in accordance with an accelerated remediation schedule.
Prepare and review qualification documentation, reports, test records, and supporting evidence.
Ensure documentation and execution practices support FDA Warning Letter remediation and regulatory inspection readiness.
Provide technical expertise and troubleshooting support for filling equipment during commissioning and qualification.