Validation Engineer

Progressive; Leiden; On-site; EUR 48,000 - 68,000; Full time

Job summary

Progressive is seeking a Validation Engineer MSAT for Biotherapeutics Drug Substance. You will join the MSAT team to support process validation activities within a growing biotherapeutics manufacturing environment.

Responsibilities include planning SPV activities, executing validation across sterilization and hold times, compiling protocols and reports, and supporting site change control with PQ activities.

Qualifications

• Master's degree in a relevant field (Bio/ Chem Eng or Biotechnology) with 0-2 years of experience
• Experience in biopharmaceutical industry or relevant academic work
• Knowledge of GMP and data integrity principles (ALCOA+)
• Understanding of validation and qualification processes in pharma

Responsibilities

• Plan and coordinate Supporting Process Validation activities
• Execute validation on mixing, buffer hold time, microbial hold time, and moist heat sterilization
• Write and review validation documentation (protocols and reports)
• Support PQ activities as part of site change control program
• Execute PQ activities in support of site change control
• Contribute to process improvements, benchmarking, and standardization
• Ensure GMP compliance and company procedures

Skills

Strong communication

Planning

Documentation

Risk management

Problem-solving

Education

Master's degree in Biochemical Engineering or Biotechnology

Bachelor's degree with 2+ years experience

Job description

Validation Engineer MSAT - Biotherapeutics Drug Substance

For an international pharmaceutical organization, we are looking for an Engineer MSAT Validation. In this role, you will be part of the Manufacturing Science & Technology (MSAT) team and play a key role in supporting process validation activities within a growing biotherapeutics manufacturing environment.

• Hours: Full-time
• Contract Duration: 12 months (with the possibility of extension)

Responsibilities:

• Plan and coordinate Supporting Process Validation (SPV) activities
• Execute validation activities related to mixing, buffer hold time, microbial hold time, and moist heat sterilization processes
• Write and review validation documentation, including protocols and reports
• Support projects as the responsible team member for performance qualification activities
• Execute performance qualification activities in support of the site change control program
• Contribute to process improvements, benchmarking, and standardization initiatives
• Ensure compliance with GMP requirements and company procedures

Requirements:

• Master's degree in a relevant field such as (Bio)Chemical Engineering or Biotechnology with 0-2 years of relevant experience, or a Bachelor's degree with 2+ years of relevant experience
• Experience within the biopharmaceutical industry or relevant academic experience
• Knowledge of GMP and data integrity principles, including ALCOA+
• Understanding of validation and qualification processes within the pharmaceutical industry
• Strong communication, planning, documentation, risk management, and problem-solving skills

Preferred:

• Experience with mixing validation, buffer hold time, microbial hold time, and moist heat sterilization qualification
• Experience with Lean, Six Sigma, or similar continuous improvement methodologies