Validation Engineer

Role name : Engineer Role Description : Validation, CSV, IQ, OQ ,PQ, FAT, SAT, Technical writer, documentation Competencies : EIS : Medical Device & Regulations Experience (Years) : 2-4 Essential Skills : Technical Writer & Validation SupportMinimum of 3 Yr exp supporting the validation of a major capital automation projectsTechnical Writing Skills1. Writing and Editingo Strong writing, grammar, and editing abilities to create clear and concise documentation.o Ability to adapt writing style to various audiences (e.g., end users, technical teams, or regulatory bodies).2. Document Design and Formattingo Proficiency with documentation tools (e.g., Microsoft Word, Adobe FrameMaker, or Google Docs).o Knowledge of design principles to create well-structured documents (manuals, user guides, SOPs, etc.).3. Version Controlo Familiarity with tools like Git, SVN, or SharePoint to manage document revisions and updates.4. Understanding of Documentation Standardso Familiarity with documentation standards such as DITA (Darwin Information Typing Architecture) or the S1000D standard.o Ability to create and maintain templates, style guides, and consistency in documentation.5. Technical Communication Toolso Experience with tools like Confluence, MadCap Flare, or HelpNDoc for creating and managing online help systems and documentation.Validation Support Skills1. Validation Knowledgeo Understanding of validation processes, especially in regulated industries (e.g., healthcare, pharmaceuticals, or software validation).o Knowledge of validation protocols like IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).2. Quality Management Systems (QMS)o Familiarity with industry standards like ISO 9001, FDA regulations (21 CFR Part 11), and GxP (Good Laboratory Practice, Good Manufacturing Practice) guidelines.o Ability to support validation documentation, such as test plans, test scripts, and validation reports.3. Testing and Documentationo Knowledge of validation testing procedures and the ability to document results accurately.o Experience with creating and maintaining test documentation, logs, and records.4. Regulatory Complianceo Knowledge of relevant regulatory standards and ensuring that validation documentation meets those requirements.5. Cross-Functional Collaborationo Ability to work with technical teams (engineers, developers, QA, and project managers) to understand and document requirements, as well as support validation efforts.6. Work experience in the medical device industry

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.