Lead Packaging and Combination Product Validation Specialist
Job Summary:
We are seeking an experienced Lead Packaging and Combination Product Validation Specialist to oversee commissioning, qualification, and validation activities for packaging and combination product assembly lines. This role requires a strong understanding of GMP regulations and data integrity principles, as well as excellent problem-solving and planning skills.
Responsibilities:
* Support C&Q Team Activities: Participate in cross-functional teams to ensure the success of projects and alignment with business goals.
* Plan and Execute Qualifications: Oversee qualifications, FAT/SAT, and commissioning activities to ensure compliance with regulatory expectations.
* Manage Documentation: Create and review validation documentation, including Validation Master Plans (VMPs), URS, IQ/OQ, IV/FV, FV, and PQ protocols.
* Qualify Equipment: Qualify packaging equipment such as vial labellers, cartoners, carton labelling systems, vision systems, printers/coders, and associated handling/inspection equipment.
* Project Planning and Progress Tracking: Support scoping, planning, and execution of validation projects, ensuring alignment with project schedules.
Requirements:
* Bachelor's degree in Engineering or relevant experience.
* Minimum 5-10 years of experience in validation roles within the Pharmaceutical/Life Sciences industry.
* Strong knowledge of packaging equipment, inspection systems, and serialization/aggregation solutions.
* Deep understanding of GMP regulations and data integrity principles.
Preferred Qualifications:
* Technical degree in Engineering.
Benefits:
This role offers a competitive salary, comprehensive benefits package, and opportunities for career growth and development.