Validation Engineer (Medical Devices, Remote)

Job summary

The Validation Engineer is tasked with the commissioning and qualification of processes and manufacturing equipment within the medical devices sector. This role involves participation in various projects, including capacity upgrades, new equipment implementation, and revalidation of existing processes.

Qualifications

• Degree in a relevant discipline.
• Minimum of 3 years of experience in a similar role, preferably in a regulated industry.
• Fluent in English, both verbal and written.
• Knowledge of GMP, cGAMP, and ISO 13485 or similar regulations is required.

Responsibilities

• Contribute to the User Requirement Specification (URS) and support the purchase and implementation of processes and manufacturing equipment.
• Review and provide input on Design Documents in accordance with cGAMP standards.
• Document deviations during Commissioning and Qualification activities.
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Write and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Ensure compliance with local EHS legislative and internal requirements during projects.
• Collaborate with cross-functional teams to maintain site-specific validation.

Skills

• Strong understanding of the Validation life cycle and its application in a compliant manner.
• Technical knowledge to challenge processes and equipment in test plans.
• Effective communication skills to interact with site-level individuals.

Education

• Engineering degree, Laboratory Technician qualification, or similar technical background.

Tools

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