Manufacturing Process Specialist, Hoofddorp, Noord-Holland

The Client 
The company is a leader in developing innovative therapies that harness the body's immune system to fight cancer. They specialize in advanced biotechnology, focusing on cell-based treatments to address serious diseases. Their work is at the cutting edge of personalized medicine and immuno-oncology.

The Role
The role focuses on supporting the manufacturing process in a regulated, GMP-compliant environment. It involves ensuring product quality, maintaining cleanroom standards, and working closely with different teams to ensure efficient and consistent production. This position requires adherence to strict procedures and the ability to work in shifts.

Responsibilities

• Assist in manufacturing operations, ensuring compliance with GMP standards.

• Maintain optimal conditions in cleanroom environments.

• Work closely with cross-functional teams to support efficient production processes.

• Handle and transfer materials, as well as review and manage batch documentation.

• Troubleshoot and resolve any issues related to processes or equipment.

• Ensure consistent, high-quality output by strictly following SOPs.

• Contribute to investigations, process improvements, and change management initiatives.

• Minimum vocational or technical school education, with experience in a regulated manufacturing environment; BSc is the highest accepted education level.

• cGMP experience in pharmaceutical or biotechnology manufacturing, or relevant internship experience.

• Knowledge of pharmaceutical manufacturing processes or biotechnology products; experience in warehouse/logistics for PST roles is a plus.

• Proficiency in Microsoft Word, Excel, and data analysis.

• Ability to work in full gowning requirements within an aseptic environment and strong attention to detail in following SOPs.

• Excellent interpersonal and communication skills in English, with a can-do attitude, punctuality, and adaptability to routine tasks and occasional changes.

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