Description

You own equipment qualification activities, including IQ, OQ, PQ, and requalification for manufacturing and laboratory equipment in a regulated environment.

This role is on-site.

Responsibilities

• Execute equipment qualification activities, including IQ, OQ, PQ, and requalification.
• Prepare, review, and execute qualification protocols and reports.
• Support commissioning, qualification, and validation activities for manufacturing and laboratory equipment.
• Collaborate with Engineering, Manufacturing, Quality Assurance, and Validation teams to ensure timely project execution.
• Review and assess vendor documentation, including FAT/SAT documentation and qualification packages.

Required Skills

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or a related discipline.
• Minimum 5+ years of experience in Equipment Qualification within the pharmaceutical, biotechnology, or medical device industry.
• Strong experience with qualification lifecycle documentation (URS, DQ, IQ, OQ, PQ, FAT, SAT).
• Familiarity with GMP regulations and validation principles.
• Experience working in manufacturing, laboratory, or cell therapy environments.
• Excellent documentation, communication, and stakeholder management skills.
• Experience supporting deviation investigations, change controls, and CAPA activities.

Preferred Skills

• Prior experience qualifying bioprocessing and cell therapy manufacturing equipment.
• Experience with Cytiva Sepax equipment is highly desirable.
• Knowledge of data integrity and computerized system interfaces associated with equipment.

Key Skills

Education

Bachelor's degree