Equipment Validation Engineer / 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

Company:

We are partnering with a leading organization in the pharmaceutical or biotech manufacturing sector, dedicated to ensuring high standards of quality and compliance within their production processes. Their technical department supports both new production lines and ongoing operations, emphasizing continuous improvement and adherence to regulatory requirements.

Job Description:

We are looking for an experienced Equipment Validation Engineer / Validation Specialist to join the Technical Support team, with a primary focus on equipment and automation validation. The role combines technical validation activities with 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.

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.

Requirements:

• Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology or equivalent.
• Minimum 5 years of professional experience in a GMP-regulated environment.
• Strong experience in Equipment and Automation Validation.
• Proven knowledge of GMP, equipment validation and automation/IS validation.
• Experience with Annex 11 and 21 CFR Part 11.
• Experience with Quality Risk Management tools such as FMEA.
• Experience reviewing validation and technical documentation from a quality perspective.
• Experience with Change Control, Nonconformances, CAPAs and quality investigations is preferred.
• Experience with statistical tools for activities such as sampling plans and hypothesis testing is preferred.
• Strong analytical, organisational and documentation skills.
• Excellent attention to detail and communication skills.
• Ability to work independently with minimal supervision and manage multiple assignments.
• Strong risk-based decision-making skills and ability to work effectively with Technical, Engineering, Operations and Quality teams.

Other Information:

• The role is hybrid, requiring at least 3 days per week onsite, ideally within an hour’s commute—relocation candidates are welcome.
• This is a 12-month contract with a strong possibility of extension, seeking long-term commitment.
• Start date is flexible; candidates with a two-month notice period are encouraged to apply.
• The position offers a competitive pay rate, open for discussion based on experience.