**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 Prepares, reviews and issues required documentation such as good practice quality guidelines and regulations (GxP) procedure manuals, quality control manuals, engineering documents, production instructions, and change authorizations in accordance with company policies, quality systems and government regulations. Implements related periodic documentation reviews. Proposes and implements change control processes. Coordinates the review and revision of procedures, specifications, and forms. Provides input on quality control procedures and R&D documentation. Applies broad theoretical job knowledge typically obtained through advanced education. May require the following proficiency: • Work is closely supervised. • Problems faced are not typically difficult or complex. • Explains facts, policies and practices related to job area. **Position Overview:** The Local MES Documentation Lead is responsible for managing all documentation activities related to the MES (Manufacturing Execution System) rollout within a GxP-regulated environment. This role ensures that all documents—including SOPs, work instructions, validation protocols, change controls, and regulatory submissions—are developed, updated, and maintained in compliance with internal standards and external regulatory requirements (e.g., FDA, EMA). The Documentation Lead plays a key role in ensuring that the MES implementation is audit-ready, fully validated, and traceable across its lifecycle. **Key Responsibilities:** + Maintain and update all MES-related documentation, including but not limited to: SOPs, Work instructions, Validation master plans, IQ/OQ/PQ protocols and reports, Functional and design specifications, Change control documentation, Risk assessments (e.g., FMEA) + Ensure documentation complies with GxP, 21 CFR Part 11, EU Annex 11, and relevant data integrity and quality standards. + Collaborate with MES project teams, IT, QA, validation, and manufacturing to capture process changes and document updates. + Lead the authoring and revision of documents related to MES change procedures and digital workflows. + Prepare documentation packages required for regulatory submissions, audits, or inspections. + Coordinate and support validation efforts including user requirements, traceability matrices, and deviation handling. + Ensure all controlled documents are reviewed, approved, and version-controlled in the eDMS. + Train relevant stakeholders on documentation requirements and processes as needed. + Participate in internal audits, CAPAs, and inspection readiness efforts related to MES implementation. + Responsible to review, update, and approve GxP-related documentation pertaining to MES rollout and associated process changes. (SOPs, WIs, PI, SAP Routers, Policies, Drawings) + Coordinate with Local and Global QA, regulatory affairs, IT, and MES functional teams to ensure alignment of documentation with business processes and compliance standards. + Responsible to initiate, track, and close document change controls through the appropriate quality systems. (CCR and CSCR request and update) + Responsible for preparing and managing documentation for submission to internal and external regulatory bodies. (Regulatory Agencies approvals) + Support to oversee the document lifecycle in electronic Document Management Systems (eDMS) **Skills & Experience:** + Deep understanding of documentation practices in a GxP-compliant manufacturing or pharmaceutical environment. + Strong knowledge of regulatory requirements including FDA 21 CFR Part 11, EU GMP Annex 11, ICH Q9, and ALCOA+ principles. + Experience with MES documentation in regulated industries (e.g., pharma, biotech, medical devices). + Proven experience managing validation documentation and system lifecycle records. + Proficiency with electronic document management systems (e.g., Veeva Vault, Master Control, Documentum, etc.). + Excellent writing, formatting, and version control skills. + Strong attention to detail and ability to manage large volumes of technical documentation. + Collaborative mindset with the ability to coordinate across cross-functional teams. **Beware of scams online or from individuals claiming to represent Convatec** A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address. If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com . **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. **Notice to Agency and Search Firm Representatives** Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. **Already a Convatec employee?** **If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!**