Biotech Validation Specialist - Aseptic & Process Quality

BioSpace; Raritan (NJ); On-site; USD 108,000 - 132,000; Full time

Benefits offered by this job

Medical Insurance

401(k) with company match

Parental leave

Job summary

Legend Biotech USA, Inc. in Bridgewater, New Jersey, is seeking a Validation Specialist to execute site validation activities, maintain the validated state, and ensure regulatory compliance for cell therapy processes.

The role covers aseptic validation, equipment qualification, and cross-functional collaboration with Technical Operations and external vendors to drive validation improvements and automation initiatives.

Qualifications

• Requires bachelor’s degree in an engineering field with relevant validation experience.
• Experience in pharmaceutical/biopharma validation or manufacturing is required.
• Knowledge of regulatory expectations and validation lifecycle.

Responsibilities

• Execute site validation activities per regulatory requirements and address deviations.
• Oversee aseptic and equipment qualification activities from protocol to reporting.
• Support process changes, material changes, and change controls with validation impact.
• Collaborate with Tech Ops and external vendors to implement automation for cell therapy.

Skills

Process validation

Equipment qualification

Aseptic processing

Quality Risk Assessments

Education

Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering or related field

Job description

Legend Biotech USA, Inc. in Bridgewater, New Jersey, is seeking a Validation Specialist to execute site validation activities, maintain the validated state, and ensure regulatory compliance for cell therapy processes.

The role covers aseptic validation, equipment qualification, and cross-functional collaboration with Technical Operations and external vendors to drive validation improvements and automation initiatives.