Validation Engineer (Medical Devices, Remote)

Job summary

The Validation Engineer will be responsible for 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.

Qualifications

• Degree in a relevant 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 and FDA requirements is preferred.

Responsibilities

• Contribute to the creation of User Requirement Specifications (URS) and support the purchase and implementation of manufacturing equipment.
• Review and provide input on Design Documents in accordance with cGAMP and related specifications.
• Execute Equipment Design Verification and document deviations during commissioning and qualification activities.
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) as per company policies.
• Write and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Ensure compliance with local EHS regulations during projects.
• Collaborate with cross-functional teams to maintain site-specific validation processes.

Skills

• Strong understanding of the Validation life cycle and Good Manufacturing Practice (GMP).
• Technical knowledge to challenge processes and ensure compliance with testing requirements.
• Effective communication skills to interact with site-level individuals and solve problems proactively.

Education

• Engineering degree or relevant technical background.

Tools

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