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QA Project Engineer MES

LocationBeerse, Belgium
Business SectorBiotechnology
Contact email
Job ref25630
Published1 day ago

Job Title: QA Project Engineer MES, CAR-T Europe

About the Role:
We are seeking a QA Project Engineer to support MES (Manufacturing Execution Systems) projects for CAR-T therapy hubs in Europe. You will help digitize documentation, ensure compliance with GMP standards, and collaborate with cross-functional teams to improve processes in an innovative therapy environment.

Key Responsibilities:

  • Lead QA activities in MES projects, including validation execution and documentation.

  • Collaborate with production and engineering teams to digitize and standardize documentation.

  • Review validation deliverables such as PQ protocols, test documentation, and traceability matrices.

  • Ensure MES solutions comply with GMP and other regulatory standards.

  • Conduct risk assessments, deviation management, and change control reviews.

  • Participate in audits, inspections, and internal quality reviews.

  • Provide QA guidance, training, and support to ensure adherence to compliance standards.

  • Contribute to lean automation initiatives and support process improvements.

  • Build strong partnerships with internal stakeholders and external partners (e.g., Legend Biotech).

  • Support QA approval of GMP documentation and attend quality review meetings.

  • Actively participate in project, operational, and system teams alongside IT and automation functions.

  • Perform other related duties as assigned.

Requirements:

  • Bio-Engineer, (Industrial) Pharmacist, or bachelor’s/master’s degree in a technical field (Engineering, Computer Science, etc.).

  • Minimum 2 years’ cross-functional experience in the pharmaceutical industry.

  • Knowledge of cGMP regulations and pharmaceutical compliance requirements.

  • Experience with master batch records and/or QA in production environments.

  • Experience with MES systems in production environments is a strong advantage.

  • Strong analytical, problem-solving, and decision-making skills.

  • Excellent communication skills and a solution-oriented mindset.

  • Ability to work independently and in a team environment.

Practical Details:

  • Location: Beerse, Belgium

  • Start Date: ASAP

  • Employment Type: Full time

  • Duration: +4 months

Interested or know someone who could be?
Send your CV to e.cabral@panda-int.com to apply or learn more.