6 jobs voor validation engineer pharma gevonden

We are looking for a Data Integrity Engineer who will be responsible for ensuring that all data generated by laboratory instruments is reliable, accurate, secure, and compliant with regulatory requirements.You will assess, improve, and safeguard data processes related to lab equipment, supporting our client in maintaining compliance and data integrity in a Gx.P environment.

Your Role

As a Data Integrity Engineer, you will:

• Perform data integrity assessments on laboratory equipment.
• Identify potential data integrity risks related to lab equipment and propose technical and procedural solutions.
• Implement and verify technical controls such as user access management, audit trails, backup & restore procedures, and electronic signatures.
• Document and optimize data flows of operational lab equipment.
• Support the creation and maintenance of SOPs and Work Instructions related to data integrity.
• Collaborate in the qualification and validation of lab equipment to ensure data integrity requirements are integrated.
• Act as a link between Quality, IT, and Laboratory teams to ensure compliant and sustainable data processes.

Qualities

• You have a Master of Science (Chemistry, Biomedical Sciences, Bio-Engineering, Pharmaceutical Sciences, etc.) or a Professional Bachelor of Science (Chemistry, Lab Technology, etc.) or equivalent through experience
• You have at least 5 years of experience in a Gx.P laboratory environment
• You have knowledge of lab equipment and the corresponding software
• You are familiar with validation and qualification processes
• You have experience with data flows and data lifecycle management
• You have risk assessment and mitigation skills
• You speak Dutch and English fluently, French is a plus

Additional assets

• You can work in a team as well as individually
• You have an eye for detail and quality
• You have a problem-solving mindset
• You are a strong communicator
• You are customer-oriented and have a consultancy mindset
• You are eager to learn new processes 

Qualities

• You have a Master of Science (Chemistry, Biomedical Sciences, Bio-Engineering, Pharmaceutical Sciences, etc.) or a Professional Bachelor of Science (Chemistry, Lab Technology, etc.) or equivalent through experience
• You have at least 5 years of experience in a pharmaceutical laboratory environment
• You have knowledge of Gx.P, equipment qualification, method validation, various lab systems, etc.
• You speak Dutch and English fluently, French is a plus

Additional assets

• You can work in a team as well as individually
• You have an eye for detail and quality
• You are a strong communicator
• You are customer-oriented and have a consultancy mindset
• You are very willing to share knowledge and experience with younger consultants