Senior Validation Engineer

Responsibilities

• Key responsibilities in this role includes, but are not limited to:
• Lead and own the development of User Requirement Specifications (URS), and drive the strategic selection, procurement, and implementation of manufacturing processes and equipment in alignment with business objectives.
• Provide expert oversight of design documentation in compliance with cGAMP standards, including Software, Hardware, and Functional Design Specifications, ensuring robustness and regulatory alignment.
• Chair and facilitate Equipment Design Reviews, ensuring that design verification activities are thorough, risk-based, and aligned with URS and regulatory expectations.
• Lead deviation management activities across Commissioning (FAT/SAT) and Qualification (IQ/OQ/PQ), ensuring timely investigation, root cause analysis, and implementation of effective corrective actions.
• Drive and oversee Commissioning and Qualification strategies, ensuring execution in line with global standards, regulatory requirements, and project timelines.
• Provide strategic input in PFMEAs, risk management activities, and project planning within Manufacturing Process Validation.
• Own the development, review, and implementation of qualification and revalidation strategies, including protocols (IQ, OQ, PQ) and reports, ensuring compliance and efficiency.
• Act as Subject Matter Expert (SME) for validation and qualification, ensuring all activities meet applicable regulatory requirements and internal quality standards.
• Lead implementation of validation lifecycle activities across equipment, processes, facilities, and products, ensuring timely delivery and alignment with project milestones.
• Ensure full compliance with internal procedures and external regulatory requirements, while continuously improving validation and compliance processes.
• Support EHS and compliance integration within projects, including CE marking requirements, ensuring safety and regulatory adherence are embedded in all activities.
• Provide technical leadership and mentorship to cross-functional teams, fostering collaboration and ensuring best practices in validation and commissioning.
• Responsible for continuous process verification strategies and ensure sustained validated state through lifecycle management of systems and processes.
• Lead the preparation and approval of Periodic System Reviews and revalidation documentation, ensuring ongoing compliance and performa

Additional Information

About Convatec Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com Position Overview: You as the Senior Validation Engineer will be responsible for leading and driving commissioning, qualification, and validation activities for manufacturing processes and equipment across the organization. The role ensures compliance, robustness, and lifecycle management of validated systems while acting as a key technical authority within projects and operations. The Senior Validation Engineer plays a central role in cross-functional projects, including: Capacity upgrades of existing processes and manufacturing equipment, including customer-driven projects Implementation of new manufacturing equipment and establishment of new facilities Introduction of new products and lifecycle support of existing products Capacity upgrades and optimization of molds and tooling Advanced Operations and continuous improvement initiatives Revalidation strategies for existing processes and systems Periodic System Reviews and lifecycle management activities to maintain the validated state The Senior Validation Engineer will participate from the first stages and throughout the projects with the purpose of: Ensure presence of and/or establish a clear User Requirement Specification. Achieving knowledge and information regarding the product, process and/or manufacturing equipment design. Achieving knowledge and background information regarding technical processes and technical solutions. Contribute to select technical solutions for handling, processing and verifications which may be subjects for commissioning and qualification. Establish and maintain relevant documentation throughout the project. Write execute and report test activities required during commissioning and qualification of the processes and/or manufacturing equipment - including testing of embedded software.

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