QA Project Engineer MES Beerse (BE) • Panda International
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Fulltime
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Engels (taal)
Aanbod
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Tijdelijk contract
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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
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