CAR-T Process Validation Engineer | Remote Options

MANTU GROUP SA; Belgique; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Health insurance

remote work

meal vouchers

a time savings account

referral bonus

Job summary

Amaris Consulting, part of Mantu, is seeking a Process Validation Engineer, Cell Therapy, to join the Manufacturing Excellence team in Ghent. You’ll drive CAR-T pilot plant validation, tech transfer, and process sterilization validation as part of a cross-functional effort to ensure compliant production.

You will contribute to writing validation documentation, leading qualification activities, and coordinating validation plans with project teams while maintaining adherence to cGMP and regulatory

Qualifications

• Bachelor’s degree or higher in Engineering, Biotechnology, Biomedical Sciences, Pharmacy, or a related field.
• Experience in pharmaceutical, biotechnology, cell therapy, human plasma-derived products, or a comparable regulated industry.
• Experience introducing pharmaceutical products into manufacturing sites, with a good understanding of manufacturing unit operations.
• Strong knowledge of current Good Manufacturing Practices and validation principles.
• Experience working in a controlled cleanroom environment under aseptic conditions is a plus.
• Strong project management, reporting, problem-solving, prioritisation, and decision-making skills.
• Ability to work independently and as part of a team, communicate with stakeholders at different levels, and work fluently in written and spoken Dutch and English.

Responsibilities

• Define, plan, and coordinate validation activities for the CAR-T pilot plant in Ghent, including PPQ, smoke studies, hold time validation, APQ, and APS.
• Provide technical guidance on process validation and equipment qualification activities.
• Lead the revalidation of manufacturing and sterilization processes.
• Write, review, and approve validation strategies, plans, protocols, reports, and related technical documentation.
• Support tech transfer, product introduction, equipment implementation, and system introduction activities.
• Review technical reports and procedures to ensure compliance with cGMP, regulatory requirements, and current industry practices.
• Contribute to process improvement projects, while tracking activities, risks, and deliverables with project teams and leadership.

Skills

Project management

stakeholder communication

team collaboration

problem solving

written and spoken Dutch & English

Education

Bachelor's degree or higher in Engineering, Biotechnology, Biomedical Sciences, Pharmacy

Job description

Amaris Consulting, part of Mantu, is seeking a Process Validation Engineer, Cell Therapy, to join the Manufacturing Excellence team in Ghent. You’ll drive CAR-T pilot plant validation, tech transfer, and process sterilization validation as part of a cross-functional effort to ensure compliant production.

You will contribute to writing validation documentation, leading qualification activities, and coordinating validation plans with project teams while maintaining adherence to cGMP and regulatory