Cell Therapy Process Validation Engineer — CPV & Data Analytics

MindCapture; Belgique; Sur place; EUR 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Expense allowance

Company car with charging card

Résumé du poste

MindCapture is seeking a Process Validation Engineer for Cell Therapy to join a consultancy role, on site with a client in Antwerp. You will drive continued process verification and particle governance for cell therapy manufacturing, collaborating with quality, QA and manufacturing teams.

You will collect, structure and analyze manufacturing data, perform statistical trending and support cross-functional governance.

Qualifications

• Bachelor degree or higher in engineering, biotechnology, biomedical sciences, pharmacy or a related discipline.
• Five to seven years of relevant professional experience.
• Experience within pharmaceutical, biotechnology, cell therapy or related regulated industry.
• Knowledge of GMP and manufacturing processes.
• Ability to perform statistical trending and interpret process data.
• Strong reporting and cross functional collaboration skills.
• Experience with cleanroom environments is a plus.

Responsabilités

• Support continued process verification activities with manufacturing science, technology transfer and quality stakeholders.
• Collect and structure manufacturing data and perform statistical trending.
• Contribute to continued process verification reporting and governance.
• Assess current particle monitoring processes and develop improved mitigation approaches.
• Document batch documentation and deviation information with cross functional teams.
• Develop and present data, trends, risk assessments and improvements.

Connaissances

GMP knowledge

Data analysis

Statistical trending

Cross-functional work

Project management

Cleanroom experience

Manufacturing knowledge

Communication skills

Independent work

Formation

Bachelor degree in engineering or life sciences

Description du poste

MindCapture is seeking a Process Validation Engineer for Cell Therapy to join a consultancy role, on site with a client in Antwerp. You will drive continued process verification and particle governance for cell therapy manufacturing, collaborating with quality, QA and manufacturing teams.

You will collect, structure and analyze manufacturing data, perform statistical trending and support cross-functional governance.