Validation Engineer (Medical Devices, Remote)

Job summary

The Validation Engineer is tasked with the commissioning and qualification of manufacturing processes and equipment, ensuring compliance with regulatory standards in the medical devices sector. This role involves participation in various projects, including capacity upgrades and new product introductions, from inception to completion.

Qualifications

• Degree in a relevant engineering or technical discipline.
• Minimum of 3 years of experience in a similar role, preferably in a regulated industry such as medical devices or pharmaceuticals.
• Fluent in English, both verbal and written.
• Familiarity with ISO 13485, FDA requirements, GMP, and cGAMP regulations.

Responsibilities

• Develop and contribute to User Requirement Specifications (URS) for manufacturing processes and equipment.
• Review and provide input on Design Documents, ensuring compliance with cGAMP standards.
• Execute Equipment Design Verification and document deviations during commissioning and qualification phases.
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities.
• Write and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Maintain documentation and ensure compliance with internal and external regulations throughout the project lifecycle.
• Collaborate with cross-functional teams to support ongoing validation efforts.
• Prepare Periodic System Review reports and manage Change Control Records.

Skills

• Strong technical knowledge of validation processes and equipment.
• Excellent problem-solving skills and ability to communicate effectively across teams.
• Proactive approach to compliance and quality assurance.

Education

• Engineering degree or equivalent technical qualification.

Tools

• Familiarity with validation tools and documentation practices in a regulated environment.