Bioprocess Validation Engineer

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

Job summary

SIRE LIFE SCIENCES in the Netherlands is seeking a Validation Engineer to support manufacturing process validation in a biopharmaceutical setting. You will coordinate validation studies across cleaning, mixing, sterilization, and hold-time programs, ensuring compliance with GMP standards and regulatory guidelines.

Responsibilities include preparing protocols, maintaining technical docs, and driving continuous improvements while ensuring audit readiness and effective cross-functional

Qualifications

• Bachelor’s degree in Science, Engineering, Biotechnology, Pharmacy or related field.
• Minimum 2 years in biopharma/pharma, process validation or MSAT.
• Experience with cleaning, mixing, sterilization validation and hold-time studies.

Responsibilities

• Plan, coordinate, and execute validation activities for equipment and supporting processes (cleaning, mixing, sterilization, hold time).
• Prepare, review, and maintain validation protocols and technical documentation.
• Support cross-functional projects with validation expertise and stakeholder coordination.
• Drive process improvements and implementation of new technologies for efficiency and compliance.
• Ensure audit and inspection readiness within biopharmaceutical regulatory requirements.

Skills

Communication

Documentation

Planning

Problem-solving

Risk management

Root cause analysis

Lean Six Sigma

Education

Bachelor's degree in Science/Engineering/Biotech/Pharmacy

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.