Freelance Validation Engineer

At Andocor, we develop and manufacture high-quality medical devices that support cardiac surgery teams around the world. To support our continued growth and commitment to quality, we are looking for a Freelance Validation Engineer who will play a key role in ensuring that our manufacturing processes, equipment and measurement systems meet the highest quality and regulatory standards.

Are you an experienced validation professional looking to make a real impact within the medical device industry? We'd love to hear from you.

Your role

As a Validation Engineer, you will be responsible for planning, coordinating and executing validation activities across our manufacturing environment. You will work closely with Quality Assurance, Production, Engineering and R&D teams to ensure compliance with applicable regulations and industry standards while supporting operational excellence.

Key Responsibilities

• Develop, execute and maintain validation plans and validation documentation.

• Define validation strategies using a risk-based approach.

• Coordinate and perform process validations, including IQ, OQ, PQ and Process Validation activities.

• Validate manufacturing equipment, production processes and measurement systems.

• Support qualification and validation activities for new equipment, processes and process changes.

• Assess change controls and CAPAs for their impact on validation status.

• Collaborate closely with Quality Assurance, Production and R&D teams to ensure compliant and efficient processes.

• Support internal audits, external audits and inspections by Notified Bodies and regulatory authorities.

• Contribute to the continuous improvement and standardization of validation procedures and methodologies.

• Master's degree in Engineering, Life Sciences, Biomedical Sciences or a related technical field.

• Minimum 3 years of experience in Validation, Quality Engineering or Process Engineering within a regulated industry.

• Experience within the Medical Device, Pharmaceutical or Life Sciences sector is highly preferred.

• Strong knowledge of validation methodologies, including IQ, OQ, PQ and Process Validation.

• Familiarity with ISO 13485, MDR 2017/745 and risk management principles.

• Strong analytical and problem-solving skills.

• Excellent organizational and documentation skills.

• Ability to work effectively in a cross-functional environment.

• Fluent in English; Dutch is considered an asset.

What we offer

• Initial assignment of minimum 4 months, with the possibility of extension.

• Availability of at least 4 days per week (80%).

• Primary workplace is our office in Hoogstraten, Belgium.

• Hybrid working arrangements can be discussed and agreed upon based on project needs and mutual agreement.

• Opportunity to work in a dynamic medical device environment with direct impact on products used in cardiac surgery worldwide.