Validation Specialist (Biopharma)

Location: Onsite at 1000 US-202, Raritan, New Jersey, United States. Work hours are 9:00 a.m. to 5:00 p.m., five days per week, 40 hours per week. Applicants must be authorized to work in the United States.

Salary: $120,000–$120,000 USD per year, plus performance-based bonus and/or equity where applicable.

Company

hirify.global is a biotechnology company developing cell therapies, including CAR-T, TCR-T, and natural killer cell-based therapies, for serious diseases.

What you will do

• Execute site validation activities, address deviations, and oversee pre-validation and validation work related to technical changes.
• Control aseptic process validation and particle runs from protocol generation through training execution and reporting.
• Support equipment process qualification and investigations of validation, qualification, and study challenges.
• Establish key performance indicators and execute routine and continued process verification reporting, including APQ/APQR data analysis.
• Assess engineering, process, raw material, consumable, packaging, and labeling changes for validation and process impact.
• Maintain manufacturing visual inspection, control strategy, and microbial control strategy programs while supporting automation platforms for cell therapy manufacturing.

Requirements

• Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, or a related field.
• At least 2 years of experience in validation or manufacturing, process, or production engineering within the pharmaceutical or biopharmaceutical industry.
• Experience with process validation, equipment qualification, or aseptic processing.
• Experience writing or supporting Quality Risk Assessments.
• United States work authorization is required; employment eligibility is verified through E-Verify.

Culture & Benefits

• Permanent full-time employees receive medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that fully vests on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid vacation, personal and sick time, floating holidays, and eleven company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, commuter benefits, family care resources, and well-being initiatives.