MSAT Validation Engineer

Engineer MSAT Validation – Biotherapeutics Drug Substance

Responsible for supporting validation activities for biotherapeutic drug substance manufacturing within a GMP-regulated biotechnology environment. The role focuses on planning, coordinating, and executing Supporting Process Validation (SPV) activities to ensure manufacturing processes remain compliant, robust, and inspection-ready. Responsibilities include validation of supporting processes such as mixing, buffer hold time, microbial hold time, and moist heat sterilization, writing and reviewing validation documentation, supporting process qualification and change control activities, driving process improvements and standardization initiatives, ensuring compliance with GMP and data integrity requirements, and collaborating with cross-functional teams to deliver clinical and commercial manufacturing projects.

Start Date: ASAP

Contract Duration: 12 months (with possibility of extension)

Location: Leiden, Netherlands

Hours: 40 hours per week

Work Arrangement: On-site

Interested in discussing this opportunity or know someone who could be a great fit? Send your CV to [email protected].

Bachelor's degree with 2+ years of relevant experience, or Master's degree in Biotechnology, (Bio)Chemical Engineering, or another relevant scientific or engineering discipline

Experience in the pharmaceutical, biotechnology, biopharmaceutical, or other GMP-regulated manufacturing environment

Working knowledge of GMP and data integrity principles (ALCOA+)

Experience with validation and qualification activities within pharmaceutical manufacturing

Knowledge of supporting process validation, including mixing validation, buffer hold time, microbial hold time, or sterilization qualification

Experience writing and reviewing validation protocols, reports, and technical documentation

Knowledge of pharmaceutical regulations and industry guidelines (FDA, EMA, WHO, ICH, ISO, ISPE, PDA)

Strong planning, documentation, communication, and problem-solving skills

Fluent English (written and spoken)

Strong stakeholder management and cross-functional collaboration skills

Ability to manage multiple validation activities and priorities simultaneously

Hands-on experience with mixing validation, microbial hold time, buffer hold time, or moist heat sterilization qualification

Experience supporting process qualification or change control programs

Experience with risk assessments, root cause investigations, and CAPA

Lean, Six Sigma, or other continuous improvement methodology experience

Knowledge of process optimization, benchmarking, and standardization initiatives