Validation Specialist

TL;DR

Validation Specialist: Execute site validation activities to meet current regulatory and site requirements with an accent on aseptic process validation, particle runs, and equipment qualification. Focus on controlling CPV/OPV and APQ/APQR reporting, assessing validation impact of engineering/process changes, and supporting investigations to keep processes in a validated state.

Company

hirify.global is a global biotechnology company developing advanced cell therapies and immunotherapies.

What you will do

• Execute site validation activities, including oversight of pre-validation and validation work driven by technical changes.
• Control aseptic process validation and particle runs from protocol generation through training execution oversight and reporting.
• Support equipment process qualification and ensure alignment with process needs defined by Manufacturing or Tech Support.
• Support investigations of validation/PQ/study challenges at the site and establish KPI with execution of routine CPV/OPV reporting.
• Provide technical assessments, rationales, and approvals for engineering and process changes to meet regulatory requirements.
• Oversee manufacturing visual inspection and microbial control strategies; assess change controls for validation impact and support cross-functional automation platform initiatives.

Requirements

• Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, or a related field.
• 2 years of experience in validation or manufacturing/process/production engineering in the pharmaceutical/biopharma industry.
• Experience with process validation, equipment qualification, or aseptic processing.
• Experience writing or supporting Quality Risk Assessments.
• Work onsite at 1000 US-202, Raritan, NJ 08869.

Culture & Benefits

• Medical, dental, and vision insurance plus a 401(k) retirement plan with company match.
• Eight (8) weeks of paid parental leave after three (3) months of employment.
• Paid time off including vacation, personal time, sick time, floating holidays, and eleven (11) company holidays.
• Flexible spending and health savings accounts, life and AD&D insurance, and short- and long-term disability coverage.
• Performance-based bonus and/or equity may be available for eligible roles.
• Benefits are offered exclusively to permanent full-time employees (contractors are not eligible).

Hiring process

• Submit a CV by email to Attn. E McShane (talent.acquisition@legendbiotech.com).