Process Validation Sepcialist
il y a 3 jours
Saint-Pierre-lès-Elbeuf
Process Validation Specialist – Pharmaceutical Manufacturing Location: Val-de-Reuil, Normandy, France Industry: Pharmaceutical / Consumer Healthcare Manufacturing Employment Type: Full-time Work Arrangement: Fully on-site About the Role A global healthcare products organization is seeking a Process Validation Specialist to join its Technical Operations team in Normandy. The role is responsible for maintaining the validated state of manufacturing and packaging processes, coordinating process validation activities, and supporting industrial transfer and technology projects. Working closely with Production, Quality, and cross-functional teams across the EMEA region, the position combines hands-on process validation, data analysis, documentation, and regulatory compliance within a highly regulated manufacturing environment. Key Responsibilities • Coordinate and execute process validation activities in accordance with the site's Validation Master Plan (VMP)., • Lead validation activities for manufacturing, bulk storage, and packaging processes., • Support the introduction of new products and materials, as well as changes to existing products, active ingredients, excipients, and primary packaging., • Develop validation protocols and reports covering feasibility, characterization, and validation stages., • Define and configure process parameters across relevant manufacturing equipment., • Collaborate with Production and Quality teams to develop batch documentation required for process validation., • Train Production and Quality Control personnel involved in validation activities., • Supervise validation batch production and conduct required sampling activities., • Analyze in-process control (IPC) and analytical testing results., • Perform statistical evaluation of validation data using tools such as Minitab and Excel., • Support investigations and deviation management associated with validation and routine production activities., • Evaluate issues and recommend appropriate corrective actions., • Maintain and periodically update relevant sections of the Validation Master Plan., • Ensure compliance with pharmaceutical current Good Manufacturing Practices (cGMP) and site quality and compliance procedures., • Contribute to site audit and inspection readiness activities., • Act as a subject matter expert during audits and regulatory inspections, including supporting preparation and presentations to auditors and inspectors., • Update process-related procedures and validation documentation as required., • Participate in industrial transfer and broader technical operations projects. Requirements • Bachelor’s degree or equivalent in a scientific discipline., • Minimum 2 years of technical experience in process validation, production, or quality within:, • Pharmaceutical manufacturing, • Medical device manufacturing, • OTC healthcare products, • Cosmetics manufacturing, • Strong knowledge of cGMP requirements, including relevant European and FDA regulations., • Proficiency in Microsoft Word, Excel, and PowerPoint., • Knowledge of statistical techniques and data-analysis tools., • Strong interpersonal and cross-functional collaboration skills., • Fluent French and English, both written and spoken. Preferred Qualifications • Knowledge of pharmaceutical manufacturing and packaging processes, including solid and/or non-solid dosage forms., • Experience working with process validation in a regulated manufacturing environment., • Strong understanding of regulatory requirements., • Experience evaluating validation data using Excel and/or Minitab., • Strong written and verbal communication skills., • Well organized, autonomous, flexible, and comfortable working hands-on in a manufacturing environment., • Strong commitment to quality, compliance, and continuous improvement. Benefits • Competitive social and benefits package., • Paid vacation and leave., • Opportunities to participate in volunteering initiatives., • Seasonal flexible time-off opportunities, including Summer Fridays where applicable., • Professional learning and development opportunities., • Employee resource groups., • Opportunities to work within a collaborative international EMEA environment.
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