Description

Key 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.Support deviation investigations, change controls, and CAPA activities associated with equipment qualification.Ensure compliance with GMP, GDP, and applicable regulatory requirements.Maintain qualification documentation and provide support during inspections and audits.Required QualificationsBachelors 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.Preferred QualificationsPrior experience qualifying bioprocessing and cell therapy manufacturing equipment.Experience with Cytiva Sepax equipment is highly desirable.Experience supporting commissioning and startup activities for new equipment installations.Knowledge of data integrity and computerized system interfaces associated with equipment.Work ArrangementThis role requires 100% on-site presence in Summit, New Jersey, USA.Ability to work closely with cross-functional project teams in a fast-paced regulated environment. Bonus Skill: Hands-on experience with Cytiva Sepax Cell Processing Systems will be considered a significant advantage

Key Skills

Education

Bachelor's degree