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.
Key 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 performance monitoring.
- Provide expert input for Change Control records, ensuring risk-based decision-making and compliance with quality systems.
- Lead audit readiness and actively support internal and external audits, acting as SME and ensuring clear, compliant documentation and responses.
- Own and drive the handling of Non-Conformances (NC) and CAPAs, including investigation, root cause analysis, implementation of corrective and preventive actions, and effectiveness checks.
- Represent validation in global/vendor interactions, including travel for supplier audits, equipment build oversight, FAT/SAT execution, and validation activities.
- Drive development and continuous improvement of quality and validation documentation (e.g., procedures, work instructions, templates), ensuring alignment with global standards and industry best practices.
Authority:
The Senior Validation Engineer can make decisions about subjects covered by the key responsibilities without any approval from Team Lead / Manager.
Skills & Experience:
- Degree in a relevant discipline.
- Experience with ISO 13485, FDA, and global regulatory requirements, with the ability to interpret, apply, and influence compliance strategies across projects and sites.
- Act with a high level of integrity and ownership, proactively identifying and escalating risks where regulatory compliance, product quality, or strategic objectives may be impacted.
- Expert-level understanding of the validation lifecycle, with a proven ability to apply risk-based and efficient validation approaches while ensuring full compliance at both local and global levels.
- Broad and in-depth experience in validation of equipment, processes, molds, and/or design, with the ability to define and drive validation strategies in complex projects.
- Strong expertise in GMP, cGAMP, and Quality Systems, with the ability to act as a Subject Matter Expert (SME) and guide others in a regulated environment.
- Excellent stakeholder management and communication skills, with the ability to influence at all organizational levels and drive alignment across cross-functional and global teams.
- Demonstrated problem-solving abilities, proactively identifying issues, challenging assumptions, and driving robust, compliant, and sustainable solutions.
- Deep technical and analytical capability, enabling critical review and challenge of process designs, manufacturing equipment, and test strategies within Commissioning and Qualification activities.
- Comprehensive understanding of testing requirements, product and material specifications, engineering drawings, and associated documentation, ensuring compliance, quality, and robustness in validation deliverables.
- Ability to mentor and develop others, sharing knowledge and best practices to strengthen team capabilities and foster a high-performance, inclusive culture.
Qualifications/Education:
- Education as Engineer, Laboratory Technician, or other relevant technical background.
- Extensive (typically 5+ years) progressive experience within validation, commissioning, or a related technical field, with a demonstrated track record of increasing responsibility and impact.
- Fluent in English (written and verbal), with the ability to communicate complex technical and regulatory concepts clearly to diverse stakeholders, including senior leadership.
- Strong knowledge and understanding of GMP, cGAMP, and ISO 13485 (or equivalent regulatory frameworks), with the ability to interpret requirements and apply them strategically across projects and operations.
- Proven experience leading validation activities in regulated industries, preferably within medical devices or pharmaceuticals, or similarly regulated sectors.
- In-depth understanding of production equipment technologies, with the ability to understand technical solutions; experience with calibration, measurement techniques, and statistical methods is preferred.
- Preferred knowledge of CE marking requirements and the Machinery Directive, with demonstrated experience ensuring compliance of process equipment within regulatory frameworks.
- Advanced proficiency in relevant digital tools (e.g., MS Excel, MS Project, PowerPoint, Word), leveraging these for data analysis, project planning, reporting, and communication at a professional level.
- Specific software skills – MS Excel, MS Project, MS PowerPoint, MS Word.
Travel Requirements
Travel activity is to be expected, approx. 20% annually, visiting suppliers in Denmark or Scandinavia, or project activities in at other Convatec sites mostly Mexico and Slovakia. This will be agreed in timely manner with direct report.
Languages
- Speaking: English Danish*
- Writing/Reading: English Danish*
*Additional language - not required, nice to have.
Working Conditions
- Hybrid working 1-2 days per week working from home driven by business requirements as Convatec has a flexible approach of working.
- This position is relevant in manufacturing facility from an office, including clean room manufacturing facility which produces medical device. Adherence to EHS & Quality standards in these areas will be mandatory.
- Office based “Hybrid Office Environment” based upon the agreement with direct report.
Ready to join us?
At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
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