Process Validation Specialist - Cell & Gene Therapy

Pauwels Consulting; Zwijnaarde; On-site; EUR 75,000 - 110,000; Full time

Job summary

Pauwels Consulting is seeking a specialist to support base business validation activities and strategic projects in a cell and gene therapy environment. You will design and implement process validation strategies to ensure cGMP readiness and process robustness.

You will draft and maintain batch records, Validation Master Plans, and related documentation, oversee PPQ, CCIT, aseptic simulations, and hold time studies, and act as SME during FDA/EMA audits.

Qualifications

• Master's degree in a relevant scientific or engineering field.
• 3+ years of experience in a cGMP biotech or biopharmaceutical environment.
• Expertise in Process Validation including PPQ, CCIT, aseptic process simulation and tech transfer.
• Knowledge of Risk Assessment methodologies and contamination control strategies.

Responsibilities

• Design and implement Process Validation activities to support the strategic plan.
• Provide technical expertise in cell and gene therapy manufacturing to establish holistic Process Control Strategies.
• Draft and maintain manufacturing batch records, Validation Master Plans, and related technical documentation.
• Design and oversee validation studies including aseptic process simulation, PPQ, CCIT, and hold time studies.
• Conduct Process Risk Assessments and provide support for change controls, deviations, and CAPAs.
• Act as a Subject Matter Expert during internal and external regulatory audits such as FDA and EMA.
• Identify process improvement opportunities and contribute to data trend analysis and Statistical Quality Control.

Skills

cGMP experience

English proficiency

Dutch proficiency

Process Validation

Regulatory readiness

Analytical thinking

Education

Master's degree in a relevant scientific or engineering field

Tools

JMP

Job description

Pauwels Consulting is seeking a specialist to support base business validation activities and strategic projects in a cell and gene therapy environment. You will design and implement process validation strategies to ensure cGMP readiness and process robustness.

You will draft and maintain batch records, Validation Master Plans, and related documentation, oversee PPQ, CCIT, aseptic simulations, and hold time studies, and act as SME during FDA/EMA audits.