Validation Engineer

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

Our client, a leading organization in the pharmaceutical and biotechnology sector, is seeking a Validation Engineer to support the validation of equipment, systems, and processes. This role ensures that facilities, utilities, and computerized systems remain compliant with regulatory and quality requirements throughout their entire lifecycle.

• Develop, execute, and review validation documentation including URS, IQ, OQ, PQ, and PV for various systems.
• Support commissioning and qualification (C&Q) 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 root cause analysis and 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.

• You have a Bachelor's or Master's degree in engineering, life sciences, pharmacy, or a related technical field.
• You bring 1+ years of relevant experience in the pharmaceutical or biotechnology manufacturing industry.
• You possess working knowledge of cGMP and regulatory frameworks such as FDA and EU GMP.
• You have experience with validation methodologies including IQ, OQ, PQ, and process validation.
• You bring knowledge of CSV and GAMP5 standards for computerized systems.
• You're a proactive team player with strong problem-solving skills and an ownership-driven attitude.
• You are fluent in Dutch and English.

Nice to Haves

• Knowledge of ICH Q7-Q12 guidelines.
• Experience with cleaning validation protocols.