CAR-T Process Validation Engineer - Pilot Plant Lead

AMARIS GROUP SA; Town of Belgium (WI); Hybrid; USD 102,000 - 136,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Consulting is seeking a Process Validation Engineer, CAR-T, to join the Manufacturing Excellence team at the Ghent site. You will drive validation activities, oversee tech transfer, and ensure cGMP compliance.

Candidates should have a degree in engineering or life sciences and hands-on experience with pharmaceutical/cell therapy validation, aseptic processing, and project management.

Qualifications

• Bachelor’s degree or higher in Engineering, Biotechnology, Biomedical Sciences, Pharmacy, or related field.
• Experience in pharmaceutical, biotechnology, cell therapy, or comparable regulated industry.
• Experience introducing pharmaceutical products into manufacturing sites; understanding of manufacturing unit operations.
• Strong knowledge of cGMP and validation principles.
• Experience in aseptic cleanroom environment is a plus.
• Strong project management, reporting, problem-solving, prioritisation, and decision-making skills.
• Ability to work independently and with teams; fluent in Dutch and English.

Responsibilities

• Define and coordinate validation activities for the CAR-T pilot plant in Ghent, including PPQ and validation studies.
• Provide technical guidance on process validation and equipment qualification.
• Lead the revalidation of manufacturing and sterilization processes.
• Write, review, and approve validation strategies, plans, protocols, reports, and related 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; track activities, risks, and deliverables with project teams and leadership.

Skills

GMP knowledge

Validation principles

Project management

Stakeholder communication

Dutch & English proficiency

Education

Bachelor’s degree or higher in Engineering, Biotechnology, Biomedical Sciences, Pharmacy, or a related field

Job description

Amaris Consulting is seeking a Process Validation Engineer, CAR-T, to join the Manufacturing Excellence team at the Ghent site. You will drive validation activities, oversee tech transfer, and ensure cGMP compliance.

Candidates should have a degree in engineering or life sciences and hands-on experience with pharmaceutical/cell therapy validation, aseptic processing, and project management.