Validation Engineer: Pharma Systems & CSV Expert

Pauwels Consulting; Antwerpen; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking a Validation Engineer to support validation of equipment, systems, and processes within a pharmaceutical/biotech setting. You will ensure facilities, utilities, and computerized systems stay compliant throughout their lifecycle.

You will develop and execute URS, IQ, OQ, PQ, and PV documentation, support C&Q activities, and coordinate with Engineering, QA, and Manufacturing to meet timelines. Fluent Dutch and English are required.

Qualifications

• Bachelor’s or Master’s degree in engineering, life sciences, pharmacy, or a related technical field.
• 1+ years of relevant experience in pharmaceutical or biotechnology manufacturing.
• Working knowledge of cGMP and regulatory frameworks such as FDA and EU GMP.
• Experience with validation methodologies including IQ, OQ, PQ, and process validation.
• Knowledge of CSV and GAMP5 standards for computerized systems.
• Proactive team player with strong problem-solving skills and ownership attitude.
• Fluent in Dutch and English.
• Nice to have: Knowledge of ICH Q7-Q12 guidelines.
• Nice to have: Experience with cleaning validation protocols.

Responsabilités

• Develop, execute, and review validation documentation including URS, IQ, OQ, PQ, and PV for various systems.
• Support commissioning and qualification activities for new or modified equipment, systems, and facilities.
• Draft and maintain validation master plans, protocols, and traceability matrices to ensure compliance.
• Coordinate with Engineering, QA, and Manufacturing teams to align validation activities with project timelines.
• Investigate deviations and non-conformances during validation execution and support CAPA follow-up.
• Assess the validation impact of proposed changes through the standard change control process.
• Maintain systems in a validated state by performing periodic reviews and re-validation as required.

Connaissances

cGMP

FDA

EU GMP

CSV

GAMP5

IQ

OQ

PQ

Process validation

CAPA

Change control

Formation

Bachelor’s or Master’s degree in engineering/life sciences/pharmacy

Description du poste

Pauwels Consulting is seeking a Validation Engineer to support validation of equipment, systems, and processes within a pharmaceutical/biotech setting. You will ensure facilities, utilities, and computerized systems stay compliant throughout their lifecycle.

You will develop and execute URS, IQ, OQ, PQ, and PV documentation, support C&Q activities, and coordinate with Engineering, QA, and Manufacturing to meet timelines. Fluent Dutch and English are required.