Quality Engineer (Pharma)

TL;DR

Quality Engineer (Pharma/MES): Reviewing and approving Master Batch Records and MES Recipes to ensure GMP compliance for commercial API production with an accent on quality assurance and regulatory standards. Focus on optimizing production systems, resolving deviations (CAPAs), and collaborating with cross-functional teams to ensure high-quality pharmaceutical output.

Location: Must be based in Belgium

Company

Independent technology consulting firm providing guidance and solutions to businesses across various sectors, including life sciences and engineering.

What you will do

• Review and approve Master Batch Records and MES Recipes for commercial APIs.
• Develop, review, and approve QA procedures and associated documentation.
• Provide quality support for optimization projects and continuous improvement initiatives.
• Assess and implement MES-related changes from a quality and compliance perspective.
• Manage investigations, deviations, CAPAs, and change controls related to MES and batch records.
• Collaborate with Production, Engineering, and IT teams to optimize site processes.

Requirements

• Bachelor’s degree or higher in Sciences, IT, Engineering, or a related field.
• 4–6 years of experience in Chemical/Pharmaceutical Supply Chain or Quality Assurance.
• Mandatory proficiency with PAS-X Manufacturing Execution System (MES).
• Fluent in Dutch and English.
• Strong understanding of production systems within a GMP environment.

Nice to have

• Familiarity with the DeltaV system.
• Knowledge of API manufacturing and cleaning validation.
• Experience working within an international or matrix organization.
• Experience in high-change environments (e.g., Launch & Grow).

Culture & Benefits

• Opportunities for rapid professional growth within a fast-expanding Belgian office.
• Access to prestigious projects with renowned pharmaceutical and biotechnology clients.
• Agile and dynamic international environment promoting meritocracy and intrapreneurship.
• Inclusive and diverse workplace committed to equal opportunity.

Hiring process

• Initial brief virtual or phone conversation to discuss motivations and fit.
• Series of interviews (average of 3) with line managers and future colleagues.
• Case study or technical assessment depending on the specific role requirements.