Bioprocess Validation Specialist

SIRE LIFE SCIENCES; Leiden; On-site; EUR 55,000 - 90,000; Full time

Job description

About the Company

Our client is a global healthcare and life sciences organization with a strong presence in the Netherlands, focused on developing innovative therapies and vaccines to address major global health challenges. The company operates in a highly regulated, technology‑driven environment and promotes a collaborative culture centered on innovation, quality, and continuous improvement.

About the Role

This role focuses on supporting manufacturing process validation activities within a biopharmaceutical production environment. The Engineer will coordinate and execute validation studies related to cleaning, mixing, sterilization, and equipment hold times while ensuring compliance with quality and regulatory standards. The position also supports process improvements, technology implementation, and operational standardization initiatives.

Responsibilities

• Plan, coordinate, and execute validation activities for manufacturing equipment and supporting processes such as cleaning, mixing, sterilization, and hold time studies.
• Prepare, review, and maintain validation protocols, reports, and technical documentation in compliance with pharmaceutical industry standards.
• Support cross‑functional projects by providing validation expertise, regular progress updates, and coordination with internal stakeholders.
• Drive process improvements, standardization initiatives, and implementation of new technologies to enhance manufacturing efficiency and compliance.
• Ensure audit and inspection readiness while maintaining adherence to quality, safety, environmental, and regulatory requirements within the biopharmaceutical environment.

Requirements

• Bachelor’s degree or equivalent qualification in Science, Engineering, Biotechnology, Pharmacy, or related technical discipline.
• Minimum 2 years of experience in the biopharmaceutical or pharmaceutical industry, preferably in process validation, manufacturing support, or MSAT environments.
• Hands‑on experience or knowledge in validation activities such as cleaning validation, mixing validation, sterilization processes, and holding time studies for manufacturing equipment.
• Strong understanding of pharmaceutical regulatory requirements and industry guidelines including FDA, EMA, ICH, ASTM, ISO, ISPE, and GMP standards.
• Excellent communication, documentation, planning, and problem‑solving skills, with experience in risk management, root cause analysis, and continuous improvement methodologies such as Lean or Six Sigma.