SME Commissioning, Pauwels Consulting

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Plaats

Beerse
2340
Antwerpen
België

Contract

Vooltijds, Onbepaalde duur

Datum gepubliceerd

2026-02-25

Online to:

2026-04-26
EUR 15.00 HOUR

SME Commissioning

Our client, a leading pharmaceutical organization, is seeking an expert to oversee commissioning and qualification activities within their production environment. The role focuses on ensuring that equipment and utilities remain in a state of control while complying with strict regulatory and business specifications.
Coordinate qualification activities and maintain technical ownership of equipment qualification files.
Review and approve qualification documentation including URS, DQ, IQ, OQ, and PQ using paperless systems.
Perform detailed assessments for projects, modifications, and remediations within a GMP environment.
Manage non-conformances and corrective actions while ensuring compliance with global regulatory guidelines.
Maintain the Validation Master Plan (VMP) and support internal and external inspections.
Serve as a coach and technical mentor to junior qualification engineers.
What are we looking for?
You have a Master's degree in a technical or scientific field.
You bring 5+ years of relevant pharmaceutical experience in a GMP-regulated environment.
You possess deep technical knowledge of aseptic and sterile equipment and manufacturing processes.
You have extensive experience in Commissioning & Qualification (C&Q) including documentation review and technical writing.
You're an effective communicator with experience in coaching or mentoring technical team members.
You are fluent in English.
Nice to Haves
Knowledge of KNEAT or similar paperless validation systems.
Active knowledge of Dutch.

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