MSAT Engineer Leiden • Oxford Global Resources

Vacature in het kort

Volledige vacaturetekst

Our client is an international biopharmaceutical organization dedicated to developing and producing high-quality drugs. With a strong focus on innovation, process optimization, and patients, the company aims to expand its manufacturing and technology operations. To strengthen the Manufacturing Science & Technology (MSAT) department, we are currently seeking a motivated Engineer MSAT Validation who will play a key role in maintaining and improving process performance and validation within a dynamic and regulated environment.

Job Description
As an Engineer MSAT Validation, you will be responsible for planning and executing validation activities related to manufacturing support processes. You will work within the Supporting Process Validation (SPV) team, focusing on the validation of equipment and systems such as cleaning, mixing, sterilization, and holding processes. In this role, you will collaborate closely with cross-functional teams to ensure that all validation procedures meet the highest regulatory and quality standards. You will contribute to continuous improvement initiatives, assist with the introduction of new technologies, and support audit readiness efforts. Your analytical mindset and attention to detail will ensure compliance, efficiency, and excellence across all technical validation activities.

Responsibilities

• Develop, coordinate, and execute validation protocols for supporting processes such as cleaning, sterilization, mixing, and holding time studies
• Prepare and review validation documentation, including protocols, reports, and technical assessments
• Collaborate with cross-functional teams to plan and schedule validation tasks and ensure alignment with project timelines
• Provide technical input for process improvements, equipment qualification, and technology implementation
• Support audits and inspections by ensuring documentation and validation records are complete and compliant
• Ensure adherence to internal policies, GMP guidelines, and applicable international regulatory standards
• Drive continuous improvement initiatives within the validation and MSAT teams

Requirements

• Bachelor's degree or equivalent in Biotechnology, Engineering, Life Sciences, or a related technical field
• Minimum of 2 years of relevant experience in the (bio)pharmaceutical industry or in an academic research environment
• Strong understanding of validation principles and experience with related documentation and reporting practices
• Knowledge of GMP regulations, quality standards, and validation guidelines (e.g., FDA, EMA, ICH, ASTM, ISPE, ISO)
• Excellent planning, coordination, and communication skills
• Analytical mindset with the ability to identify and resolve technical challenges
• Experience with Lean, Six Sigma, or other process optimization methodologies is a plus

Benefits

• Region: South Holland
• Contract: 1 year trough Oxford Global Resources, potential for extension or permanent hire
• Working hours: Full-time position with hybrid working options
• Salary: between €3500 and €5500 gross monthly, based on experience and qualifications
• Opportunity to work in a high-impact role within a global biopharmaceutical environment
• Inclusive, collaborative, and innovation-driven company culture
• Vacancy number: 26611