Job Title: Commissioning & Qualification (C&Q) Engineer

Location: Rahway, New Jersey

Contract Length : 24 Months

Project Overview:

I-Pharm GxP are looking for a skilled C&Q Engineer to support a pilot plant designed as a launch facility for Antibody Drug Conjugates (ADCs) and oncology ingredients. This facility will handle OEB-4 and OEB-5 materials for development and clinical trials. The project team has expertise in biologics and ADCs but requires additional support for OEB-4 and OEB-5 handling and related equipment requirements.

Key Responsibilities:

• Containment & Isolation Equipment:
• Provide expertise in handling and qualifying isolators, glove boxes, steam hoods, and containment systems. Ensure containment protocols for OEB-4 and OEB-5 level materials are strictly followed, focusing on operational safety and contamination control.
• Negative Pressure Room Setup:
• Implement and validate negative pressure rooms to maintain safe working environments. Oversee room pressurization requirements to meet containment standards for high-potency compounds.
• Component Impact Assessment & URS Development:
• Conduct comprehensive component impact assessments to ensure compatibility with OEB-4 and OEB-5 standards. Collaborate on User Requirement Specification (URS) development for equipment and systems, tailoring requirements to high-potency material handling.
• Factory Acceptance Testing (FAT) Readiness:
• Lead FAT readiness assessments for new equipment, working closely with vendors to ensure all specifications meet GMP and containment criteria.
• Protocol Writing and Execution:
• Develop and execute qualification protocols, including commissioning and validation of equipment and systems specific to handling high-potency compounds.

Required Skills & Experience:

• Proven experience with isolators, glove boxes, steam hoods, and containment systems.
• Deep knowledge of OEB-4 and OEB-5 standards, including safe handling, containment, and negative pressure room setups.
• Strong background in protocol writing, URS development, and component impact assessment.
• Experience in FAT preparation and execution for high-containment systems.
• Ability to communicate complex technical requirements effectively with cross-functional teams, especially in a biologics and ADC environment.

This role is essential to establishing a safe, compliant, and efficient pilot plant facility for ADC and oncology ingredient launches, ensuring readiness for clinical trials and development.

Please apply to the link attached or alternatively please reach out to me directly at: