Biotherapeutics Process Validation Engineer (MSAT)

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

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.