Project Engineer

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.