Hybrid Equipment & Automation Validation Specialist

SIRE LIFE SCIENCES; Breda; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Hybrid work arrangement

Relocation welcome

Job summary

SIRE LIFE SCIENCES in the Netherlands is seeking an experienced Equipment Validation Engineer to join the Technical Support team. The role focuses on equipment and automation validation, quality documentation review, risk management, and engineering support.

The successful candidate will work independently, manage multiple assignments, and provide specialist expertise within a relatively junior team. A master’s degree and at least 5 years GMP experience are required, with hybrid onsite work.

Qualifications

• Master's degree in Engineering, Pharmaceutical Sciences, Process Technology or equivalent.
• Minimum 5 years of GMP-regulated experience.
• Strong experience in equipment and automation validation.
• Proven knowledge of GMP, validation and IS validation.
• Experience with Change Control, Nonconformances, CAPAs and quality investigations.
• Experience with statistical tools for sampling plans and hypothesis testing.
• Excellent attention to detail and communication skills.
• Ability to work independently across multiple assignments.

Responsibilities

• Execute and support equipment and automation validation activities for existing production equipment.
• Review and approve validation documentation to ensure GMP, corporate, site and regulatory requirements are met.
• Provide QA and quality engineering support for validation activities, testing strategies and investigations.
• Support Quality Risk Management activities, including risk assessments, pFMEA and QRAES.
• Review and approve technical changes to equipment, parameters and Maintenance & Engineering procedures.
• Perform quality review of technical change controls and ensure required assessments are complete.
• Provide guidance to Operations and Technical teams on quality policies, standards and procedures.
• Support validation-related investigations, Nonconformances, CAPAs and change controls.
• Ensure validated systems and equipment remain compliant and properly documented.
• Manage multiple assignments independently and deliver quality objectives according to project requirements.

Skills

GMP knowledge

Equipment validation

Automation validation

Annex 11/21 CFR

FMEA

Change control

CAPA investigations

Documentation review

Statistical tools

Education

Master's degree in Engineering/Pharma/Process Technology

Job description

SIRE LIFE SCIENCES in the Netherlands is seeking an experienced Equipment Validation Engineer to join the Technical Support team. The role focuses on equipment and automation validation, quality documentation review, risk management, and engineering support.

The successful candidate will work independently, manage multiple assignments, and provide specialist expertise within a relatively junior team. A master’s degree and at least 5 years GMP experience are required, with hybrid onsite work.