Engineer MSAT Validation

SIRE LIFE SCIENCES; Leiden; On-site; EUR 52,000 - 76,000; Full time

Job summary

The Company in Leiden is seeking an Engineer MSAT Validation to support process validation activities within biologics drug substance manufacturing. You will collaborate with technical, quality, and manufacturing teams to ensure validated, compliant, and optimized processes.

Ideal candidates hold a Master’s degree (or Bachelor + 2+ years) and possess knowledge of GMP, ALCOA+ data integrity, and validation activities, with fluent English communication.

Qualifications

• Master’s degree with up to 2 years of relevant experience, or Bachelor’s with 2+ years in industry.
• Experience in a biopharmaceutical, pharmaceutical, or regulated manufacturing environment.
• Knowledge of GMP regulations and ALCOA+ data integrity principles.
• Understanding of validation and qualification activities.
• Fluent English communication and strong documentation skills.

Responsibilities

• Plan, coordinate, and execute process validation activities.
• Conduct mixing validation, buffer hold time validation, microbial hold time validation, and moist heat sterilization validation.
• Prepare, review, and maintain validation protocols, reports, and support documentation.
• Support validation and qualification activities for both new and existing manufacturing processes.
• Execute performance qualification activities related to change controls and improvement projects.
• Collaborate with cross functional teams to deliver validation activities according to project timelines.
• Ensure GMP compliance and ALCOA plus data integrity principles.
• Identify opportunities for process optimization, standardization, and continuous improvement.
• Support adherence to quality, safety, and regulatory requirements.

Skills

GMP knowledge

ALCOA+ data integrity

Validation methods

Documentation

Project planning

English communication

Education

Master’s degree in Biotechnology

Master’s degree in Biochemical Engineering

Bachelor’s degree in related field

Job description

The Company

A leading biopharmaceutical manufacturing organization focused on the development and production of high-quality biologic medicines. The company operates in a highly regulated environment and is committed to innovation, quality, compliance, and continuous improvement across its manufacturing processes.

About the Role

We are seeking an Engineer MSAT Validation to support process validation activities within biologics drug substance manufacturing. This role focuses on ensuring manufacturing processes are validated, compliant with regulatory requirements, and optimized for commercial production. You will work closely with technical, quality, and manufacturing teams to execute validation projects and drive operational excellence.

Responsibilities

• Plan, coordinate, and execute supporting process validation activities
• Conduct mixing validation, buffer hold time validation, microbial hold time validation, and moist heat sterilization qualification
• Prepare, review, and maintain validation protocols, reports, and support documentation
• Support validation and qualification activities for both new and existing manufacturing processes
• Execute performance qualification activities related to change controls and improvement projects
• Collaborate with cross functional teams to deliver validation activities according to project timelines
• Ensure compliance with GMP requirements and ALCOA plus data integrity principles
• Identify opportunities for process optimization, standardization, and continuous improvement
• Support adherence to quality, safety, and regulatory requirements

Requirements

• Master’s degree in biotechnology, Biochemical Engineering, Chemical Engineering, or a related discipline with up to two years of relevant experience
• Alternatively, a bachelor’s degree with at least two years of industry experience
• Experience in a biopharmaceutical, pharmaceutical, or regulated manufacturing environment
• Knowledge of GMP regulations and ALCOA plus data integrity principles
• Understanding of validation and qualification activities
• Familiarity with pharmaceutical guidelines including FDA, EMA, WHO, ISO, ICH, ISPE, and PDA
• Strong communication, planning, documentation, and problem-solving skills
• Fluent English communication skills