Validation Engineer

Job Summary We are seeking an experienced CQV Engineer / Validation Specialist to support Commissioning, Qualification, and Validation activities within a cGMP-regulated Clinical and Commercial Cell Therapy Manufacturing facility. This role will support facility, equipment, utility, system, and process validation activities while ensuring compliance with FDA and GMP requirements. The ideal candidate will have strong experience in aseptic manufacturing environments, validation protocol execution, documentation management, and cross-functional collaboration within pharmaceutical or biotech manufacturing operations. Key Responsibilities Support Commissioning, Qualification, and Validation (CQV) activities for manufacturing equipment, facilities, systems, and processes Execute validation protocols, testing activities, and qualification documentation in compliance with cGMP and FDA regulations Manage deviations, remediation efforts, corrective actions, and issue resolution activities Author and execute Batch Records, SOPs, Work Instructions, and CQV protocols Support regulatory inspections, internal audits, and compliance initiatives Collaborate with Engineering, Manufacturing, Quality, Validation, and external vendors Identify gaps in systems or processes and support continuous improvement initiatives Maintain accurate validation documentation and ensure audit readiness Support safe and compliant manufacturing operations for personalized cell therapy production Required Qualifications Bachelor's Degree required Minimum 8 years of CQV experience in GMP/FDA-regulated environments Experience supporting aseptic manufacturing operations Strong understanding of cGMP requirements and validation practices Experience with protocol execution, deviation management, and remediation activities Strong technical writing and documentation experience Preferred Systems Experience Maximo Siemens EMS Comet Kneat Kaye AVS Kaye Valprobe Preferred Skills Commissioning & Qualification Process Validation Equipment Qualification GMP Compliance FDA-Regulated Manufacturing Batch Record Review SOP Development Audit Support Change Control CAPA & Remediation Cross-Functional Collaboration Problem Solving & Troubleshooting What We're Looking For Strong communication and organizational skills Ability to work independently in fast-paced manufacturing environments Detail-oriented with strong compliance mindset Team-oriented professional capable of driving projects with minimal oversight

Pay:

$40.00 - $44.00 per hour

Experience:

Validation Support:

3 years (Required)

GMP:

4 years (Required) Ability to

Commute:

Raritan, NJ 08869 (Required)

Work Location:

In person