MSAT Engineer

SIRE LIFE SCIENCES; Hoofddorp; On-site; EUR 60,000 - 90,000; Full time

Job summary

SIRE LIFE SCIENCES is seeking a Manufacturing Operations and Compliance Support professional to ensure smooth commercial production of cell‑based therapies within a GMP regulated environment.

You will contribute to investigations, product release support, and continuous improvement while collaborating with cross‑functional teams to uphold regulatory standards and quality systems.

Qualifications

• GMP knowledge and pharmaceutical manufacturing standards are essential.
• Experience with deviation investigations and root-cause analyses.
• Strong documentation and technical reporting skills.
• Excellent communication and collaboration across teams.

Responsibilities

• Perform impact assessments to support product release activities.
• Lead deviation investigations using root cause analysis methodologies.
• Develop and manage corrective and preventive actions (CAPA).
• Collaborate with manufacturing, quality, and technical teams to resolve issues.
• Author and review SOPs, batch records, and GMP documentation.
• Support change control processes and process improvements.
• Contribute to manufacturing projects and operational excellence.
• Ensure compliance with regulatory standards and internal quality systems.

Skills

GMP knowledge

Root cause analysis

CAPA processes

Documentation

Cross-functional collaboration

Process improvement

Quality systems

Education

Bachelor's degree in biochemical/chemical engineering or related field

Job description

Company

A global organization operating in advanced biopharmaceutical manufacturing, focused on innovative therapies and strict quality and compliance standards. The company supports cutting‑edge production processes in highly regulated environments to deliver life‑changing treatments.

Role Description

This role focuses on supporting manufacturing operations within the Manufacturing Science and Technology function. The position plays a key role in ensuring smooth commercial production of cell‑based therapies while maintaining compliance with regulatory requirements. You will be involved in process investigations, product release support, and continuous improvement initiatives while working closely with cross‑functional teams.

Responsibilities

• Perform impact assessments to support product release activities
• Lead and support deviation investigations using root cause analysis methodologies
• Develop and manage corrective and preventive actions
• Collaborate with manufacturing, quality, and technical teams to resolve issues
• Author and review SOPs, batch records, and GMP documentation
• Support change control processes and process improvements
• Contribute to manufacturing projects and operational excellence
• Ensure compliance with regulatory standards and internal quality systems

Requirements

• Bachelor’s degree in biochemical engineering, chemical engineering, biotechnology, or related field
• Engineering background preferred
• Experience with cell culture, cell therapy, or aseptic manufacturing
• Strong knowledge of GMP and pharmaceutical manufacturing standards
• Hands‑on experience with deviation investigations, root cause analysis, CAPA, and change control
• Experience in technical documentation and report writing
• Strong understanding of biopharmaceutical manufacturing processes
• Excellent communication and collaboration skills

Other Information

Department: Manufacturing Science and Technology

Function: Manufacturing Operations and Compliance Support

Work environment: GMP regulated production setting