Senior CSV Engineer for MES Validation & GMP Compliance

SIRE LIFE SCIENCES; Hoofddorp; On-site; EUR 70,000 - 95,000; Full time

Job summary

SIRE LIFE SCIENCES is seeking a Senior Quality Engineer I – CSV to join a quality team supporting Manufacturing Execution System projects. You will provide quality oversight for computer system validation activities, ensuring MES and related systems remain compliant with GMP and regulatory requirements.

You will collaborate closely with engineering, validation and manufacturing teams while helping drive quality improvements across the site, reviewing validation documentation, and supporting CQV

Qualifications

• Proven experience with CSV in GMP-regulated pharma/biotech/medical device environments.
• Strong technical writing and communication skills.
• Experience reviewing and approving validation documentation.
• Ability to work independently and collaborate with multidisciplinary teams.

Responsibilities

• Provide quality oversight for CSV activities related to MES projects.
• Review and approve validation documentation (new qualifications, changes, revalidations).
• Ensure computerized systems comply with GMP and regulatory expectations.
• Support CQV activities from a quality perspective.
• Participate in Quality Risk Management and assess impact of changes.
• Help develop and monitor quality KPIs for continuous improvement.
• Investigate quality deviations and contribute to CAPAs.
• Collaborate with engineering, validation and manufacturing to maintain compliance.
• Contribute to process improvements and inspection readiness.

Skills

CSV validation experience

GMP compliance

Quality systems

Documentation review

Independent worker

Education

Bachelor's degree in Engineering/Life Sciences/CS

Tools

Werum PAS-X

Job description

SIRE LIFE SCIENCES is seeking a Senior Quality Engineer I – CSV to join a quality team supporting Manufacturing Execution System projects. You will provide quality oversight for computer system validation activities, ensuring MES and related systems remain compliant with GMP and regulatory requirements.

You will collaborate closely with engineering, validation and manufacturing teams while helping drive quality improvements across the site, reviewing validation documentation, and supporting CQV