Senior Equipment Validation Specialist (GMP)

SIRE LIFE SCIENCES; Breda; On-site; EUR 70,000 - 90,000; Full time

Job summary

SIRE LIFE SCIENCES is seeking an experienced Equipment Validation Specialist to join a technical support team ensuring manufacturing equipment and systems comply with GMP standards.

You will lead validation activities on existing production lines, review validation documentation, and support risk assessments and continuous improvement. Flexible to relocate or commute within about one hour for a December start in the Netherlands.

Qualifications

• Minimum of 5 years of professional experience in GMP environments, specifically in equipment validation.
• Strong expertise in equipment validation and documentation review.
• Proven ability to work independently and deliver high-quality results.
• Experience with quality review of validation packages and risk management tools.
• Excellent attention to detail and ability to handle large amounts of technical documentation.
• Strong communication skills and a structured, organized approach to work.
• Comfortable working within a team of junior professionals, providing guidance as needed.

Responsibilities

• Lead and support equipment validation activities independently across existing production lines.
• Review and approve validation documentation, ensuring compliance with internal standards, GMP, and regulatory requirements.
• Support technical documentation and validation deliverables, maintaining accuracy and completeness.
• Assist in risk assessments related to equipment and validation processes, identifying potential issues and mitigation strategies.
• Review validation data, change requests, and validation investigations, ensuring high-quality documentation.
• Collaborate with cross-functional teams, providing technical guidance and ensuring validation processes align with quality policies.
• Support deviation investigations, CAPAs, and continuous improvement activities related to validation.

Skills

GMP compliance

Equipment validation

Documentation review

Risk management

Independent worker

Communication skills

Team guidance

Job description

SIRE LIFE SCIENCES is seeking an experienced Equipment Validation Specialist to join a technical support team ensuring manufacturing equipment and systems comply with GMP standards.

You will lead validation activities on existing production lines, review validation documentation, and support risk assessments and continuous improvement. Flexible to relocate or commute within about one hour for a December start in the Netherlands.