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À propos
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This role supports validation activities across multiple systems and equipment areas.
Your New Job: Primary responsibilities for the Validation Engineer include the following: Project validation support including conducting equipment performance qualifications (specifically cleaning and sterilization validation) Authoring project validation master plans; SOP and documentation updates; Authoring validation protocols and final reports, executing validation studies, analysis of validation data, resolving technical issues encountered during study execution.
Key Duties and Responsibilities: Design, author, review, approve and execute validation and qualification documentation, including cycle development studies.
Develop and manage change controls, deviations and investigations.
Troubleshoot and resolve technical issues during validation execution.
Perform root cause analysis of equipment and system failures.
Collaborate with Production, Maintenance and Quality teams during qualification and performance activities.
Support continuous improvement initiatives (e.g., Lean Six Sigma).
Represent Validation in cross-functional projects and technical forums.
Ensure compliance with regulatory requirements and cGMP standards.
Support audits, inspections and regulatory submissions as required.
Promote a safe, compliant and quality-focused culture.
What Are We Looking For? Relevant qualification in Pharmaceutical, Biological, Chemical Sciences or Engineering.
Proven experience in validation within a GMP manufacturing environment.
Strong knowledge of equipment and process validation, including CTU qualification and thermal mapping.
Experience with deviation management, change control and technical investigations.
Ability to analyse complex data and link findings to equipment performance.
Experience leading technical projects.
Knowledge of sterile fill-finish processes and associated equipment.
Familiarity with process monitoring/automation systems (e.g., DeltaV, PI) desirable.
Strong documentation, report writing and communication skills.
Proficient in Microsoft Office and related applications.
Compliance Statement: By applying, you are giving consent for Matrix Recruitment to contact you about this job.
We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy.
All CVs are treated in strict confidence and will not be submitted to any client without your prior knowledge and permission.
Please note that due to the high volume of applications, we can only respond to candidates who meet the criteria for the role. xcfaprz
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Compétences linguistiques
- English
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