Senior Quality Engineer – Computer System Validation

SIRE LIFE SCIENCES; Hoofddorp; On-site; EUR 70,000 - 110,000; Full time

Job summary

SIRE LIFE SCIENCES is seeking a Senior Quality Engineer specializing in Computer System Validation (CSV) to support MES projects and uphold validation integrity across the organization. The role focuses on ensuring regulatory compliance and GMP standards in a fast-paced manufacturing environment.

You will review validation deliverables, drive continuous improvement, collaborate with cross-functional teams, and manage priorities independently while maintaining rigorous quality oversight.

Qualifications

• Proven experience in computer system validation within regulated environments.
• Strong understanding of GMP and regulatory standards.
• Ability to review and approve validation deliverables.
• Good communication and collaboration skills.
• Ability to work independently on routine tasks and manage multiple priorities.

Responsibilities

• Support development and tracking of KPIs to drive continuous improvement initiatives.
• Develop strategies to implement changes to processes and procedures.
• Review and approve all CSV validation deliverables, including initial qualification, change control validation, and periodic revalidations.
• Build a working knowledge of products and contracts to ensure quality standards are met.
• Collaborate effectively with cross-functional teams, contributing to organizational processes.
• Prioritize tasks to meet departmental goals, working independently where appropriate.
• Ensure compliance with regulatory requirements and maintain GMP standards.
• Develop solutions for complex problems, evaluate deviations, and assess their impacts.
• Oversee inspections, statistical process control analyses, and audits to enforce quality requirements.
• Support compliance audits and contribute to quality oversight activities, including CQV and Risk Management.

Skills

CSV validation

GMP knowledge

Documentation review

Communication

Independent work

Job description

Company

A leading organization in the healthcare and manufacturing industry, dedicated to delivering high-quality products through innovative processes and rigorous quality standards. The company emphasizes continuous improvement, regulatory compliance, and operational excellence.

Job Description

We are seeking a skilled Senior Quality Engineer specializing in Computer System Validation (CSV) to join our team. This role is vital in supporting MES projects, ensuring compliance, and maintaining the integrity of validation activities across the organization.

Responsibilities

• Support the development and tracking of KPIs to drive continuous improvement initiatives.
• Develop strategies to implement changes to processes and procedures.
• Review and approve all CSV validation deliverables, including initial qualification, change control validation, and periodic revalidations.
• Build a working knowledge of products and contracts to ensure quality standards are met.
• Collaborate effectively with cross-functional teams, contributing to organizational processes.
• Prioritize tasks to meet departmental goals, working independently where appropriate.
• Ensure compliance with regulatory requirements and maintain GMP standards.
• Develop solutions for complex problems, evaluate deviations, and assess their impacts.
• Oversee inspections, statistical process control analyses, and audits to enforce quality requirements.
• Support compliance audits and contribute to quality oversight activities, including CQV and Risk Management.

Requirements

• Proven experience in computer system validation within regulated environments.
• Strong understanding of GMP and regulatory standards.
• Ability to review and approve validation deliverables.
• Good communication and collaboration skills.
• Ability to work independently on routine tasks and manage multiple priorities.

58654