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 such as medical devices or pharmaceuticals.
• 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 manufacturing processes and equipment.
• Review and provide input for Design Documents in accordance with cGAMP standards.
• Execute Equipment Design Verification and document deviations during commissioning and qualification activities.
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) in line with company policies.
• Write and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Ensure compliance with local EHS legislative requirements during projects.
• Collaborate with cross-functional teams to maintain site-specific validation processes.

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 and proactively solve problems.

Education

• Education as an Engineer, Laboratory Technician, or other relevant technical background.

Tools

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