Process Validation Consultant

Pauwels Consulting; Oost-Vlaanderen; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking a specialist to support base business validation activities and strategic projects in a biotechnology setting. This role focuses on designing and implementing process validation strategies to ensure cGMP readiness and robust processes within cell and gene therapy.

You will design validation studies, contribute to risk assessments, and serve as SME during regulatory audits. English and Dutch language skills are required, with 3+ years of cGMP biotech experience.

Qualifications

• Master’s degree in a relevant scientific or engineering field.
• 3+ years in a cGMP biotech or biopharmaceutical environment.
• Experience with Process Validation including PPQ, CCIT, aseptic process simulation.

Responsabilités

• 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.

Connaissances

Process Validation

Risk Assessment

Statistical Analysis

Multitasking

English

Dutch

Formation

Master's degree

Outils

JMP

Description du poste

Our client, a leading biotechnology organization, is seeking a specialist to support base business validation activities and strategic projects. This role involves designing and implementing process validation strategies to ensure cGMP readiness and process robustness within a cell and gene therapy environment.

Responsibilities

• Participate in the design and implementation of 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.

Requirements

• You have a Master's degree in a relevant scientific or engineering field.
• You bring 3+ years of experience in a cGMP environment within the biotech or biopharmaceutical industry.
• You have expertise in Process Validation including PPQ, CCIT, aseptic process simulation, and tech transfer.
• You possess knowledge of Risk Assessment methodologies and contamination control strategies.
• You bring experience with statistical analysis software such as JMP.
• You're proactive, analytical, and able to manage multiple priorities in a dynamic, matrixed environment.
• You are fluent in English and Dutch.

Nice to Haves

• Direct experience within cell and gene therapy manufacturing processes.
• Knowledge of French.