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.