Validation Engineer

仕事内容

Job description:

• Create comprehensive validation plans to ensure transferred processes meet quality and compliance requirements.
• Examine and approve validation plans prepared by CMOs to ensure alignment with GSK standards.
• Develop a Difference Analysis to compare GSK’s validation strategies with those of the CMO, identifying and addressing any discrepancies.
• Prepare documents that leverage previous validation data to support new validation processes.
• Assess and review comparison documents and technical risk assessments to ensure completeness and accuracy.
• Evaluate the CMO’s capability to perform necessary validations by analyzing differences in validation strategies.
• Ensure CMO validation plans meet GSK’s standards and requirements.
• Develop specific validation plans for GSK processes.
• Examine and approve validation protocols and reports to ensure compliance.
• Verify that validation documents are correctly included in regulatory submission files.
• Ensure the CMO’s validation summary reports are complete and accurate.

Requirements:

• Minimum of 6 years of experience in validation.
• Excellent communication skills, with the ability to work effectively in a matrix organization.
• Perfectly bilingual in French and English, with projects involving the USA and Italy. Native English speakers are also welcome.
• Strong background in validation processes, with experience in technical support and troubleshooting.

Offer:

For this position of Validation Engineer, we offer an attractive salary with the following benefits:

• Group & hospitalisation insurance
• 7 euros meal voucher per working day
• Reimbursement km or company car
• Monthly allowance (80 euros net per month)
• A 13th month
• Training

A rate as a freelancer is also possible.