PROCESS & VALIDATION EXPERT

About the Role Responsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
Responsible for scale-up and line transfer by developing and executing a validation strategy according to cGxP for scale-up and line transfers and alignment with all the sites.
Executing and managing process, primary packaging, and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations.
Your key responsibilities.
Your responsibilities include, but are not limited to.
• Support Product Steward in maintaining the process control strategy.
• Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
• Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
• Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams • Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed.
• Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach.
Provide technical expertise for pre-validation / validation strategy.
• Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV).
• Ensure that all manufacturing and cleaning processes are validated; overview on state of validation at site is maintained.
• Establish and monitor validation KPIs.
• Maintain all validation activities in an inspection ready status.
• Author validation protocols and reports.
• Support MS&T activities in ensuring that responsible departments execute and maintain the VMP activities.
• Partner with Engineering, IT, QC, AS&T to define the interfaces to equipment qualification / utilities qualification, system qualification, analytical method validation.
• Provide all necessary information to perform the validation documentation, align with stability experts and QC labs to organize the stability samples.
Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements What you’ll bring to the role.
• Scientific or Engineering Degree.
• 5 years experience in executing equipment qualifications, process validation, having led and managed validation projects, including sterile manufacturing.
• Ideally also 5 years experience in manufacturing, MS&T or quality.
• Expert in reviewing and writing technical reports.
• Proven project management experience in a cross-functional • Fluent in Italian and English.
Work location.
Saluggia (VC).