Validation Engineer - Cell Therapy (Onsite, Summit, NJ)

Validation Engineer Cell Therapy (Onsite, Summit, NJ)

We are looking for a Validation Engineer for our client, a Global Biopharmaceutical Company. You will support the successful implementation of various process / lab equipment at multi-use sites through interaction with internal customers and external service providers.

The incumbent in this is tasked with commissioning and qualifying new equipment facilities, and utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures.

This is a 40-hour per-week, 6-month contract, 100% Onsite role in Summit, NJ (The candidate must be able to work onsite 5 days a week).

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Responsibilities :

Maintains qualified equipment systems in compliance with policies, guidelines, and procedures : Develops qualification protocols, and associated reports while adhering to a change management process.

Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions.

Develops written procedures for calibration and preventive maintenance of equipment. Supports equipment qualification and validation activities.

Develop validation / qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.

Manages projects of limited scope and complexity within their functional area : Supports equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turnover to the business area.

Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.

Completes all qualification and validation documentation with accuracy, completeness, and compliance to Celgene standards.

Provides excellent customer service and support : Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.

Provides technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being met.

Provides technical support and guidance on equipment and computer systems qualification and validation issues. Maintains a positive relationship with all team members and site customers while promoting a positive team environment.

Regulatory Responsibilities Ensure equipment, facilities, and programs are maintained in compliance. May be called upon as SME in both internal and regulatory audits.

Requirements :

• 5+ years of relevant work experience in Validation is required, preferably in a pharmaceutical manufacturing environment
• Minimum of 3 years experience in equipment, facility, or utility qualification
• Knowledge of cGMP, GXP, GAMP, and SDLC regulations, including 21CFR part 11, computer systems validation requirements, and good documentation practices.
• Experience in the qualification of cell therapy equipment is a plus
• Understanding investigations, deviations, and CAPA management in the regulated pharmaceutical industry.

Please submit your resume to our network at / careers / (please apply to the Validation Engineer Cell Therapy (Onsite, Summit, NJ) role).