Filling Line Qualification Specialist

We are seeking an experienced Filling Lines Qualification Engineer with strong hands-on Commissioning, Qualification, and Validation (CQV) experience in pharmaceutical or biotechnology manufacturing. The ideal candidate will have direct expertise with Norden filling equipment, particularly ointment and semi-solid tube filling systems incorporating crimping and ultrasonic sealing of polyfoil tubes.

The successful candidate will lead and support qualification activities for a critical filling platform, including IQ/OQ/PQ, SIP cycle development and qualification, smoke studies, environmental monitoring qualification, and disinfection qualification. This role requires strong technical judgment, protocol development capabilities, and the ability to design qualification approaches for equipment and processes that are new to the site.

Develop, review, and execute commissioning and qualification protocols, including IQ, OQ, and PQ, for Norden ointment tube filling equipment.
Lead or support SIP cycle development, optimization, and qualification for the ointment filling platform.
Design SIP qualification approaches where established site procedures are not available, including defining cycle parameters, acceptance criteria, and qualification requirements.
Evaluate SIP cycle performance in consideration of the product's low moisture tolerance and moisture-sensitive critical quality attributes (CQAs).
Plan, coordinate, and execute smoke studies to demonstrate appropriate airflow patterns and support environmental/aseptic process qualification.
Support environmental monitoring process qualification and ensure appropriate integration with smoke study and disinfection activities.
Develop, review, and execute disinfection qualification protocols.
Coordinate SIP, smoke study, environmental monitoring, and disinfection qualification activities to ensure efficient execution of interrelated workstreams.
Review existing equipment and process specifications and translate approved requirements into executable C&Q protocols.
Review completed FAT/SAT documentation and use it as a qualification basis while identifying, documenting, and closing any outstanding gaps.
Develop qualification strategies, test scripts, acceptance criteria, and supporting documentation in accordance with site procedures and GMP requirements.
Identify and document deviations, discrepancies, and qualification gaps and support their timely resolution.
Collaborate with CSV and AI validation teams on cross-functional deliverables associated with the broader remediation program.
Work closely with Engineering, Manufacturing, Quality, Microbiology, and equipment vendors to coordinate qualification activities.
Ensure qualification activities and documentation meet FDA, GMP, and regulatory remediation expectations.
Prepare comprehensive qualification reports and supporting documentation suitable for regulatory inspection.
Provide technical troubleshooting and qualification support throughout commissioning and execution.