| Urgent Opening_____Validation Engineer____Puerto Rico, TX (Onsite) at Rico, Colorado, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2124952&uid= From: Avinash Kumar, Altitude Technology Solutions Inc [email protected] Reply to: [email protected] Hi, Hope you are doing well!! I am trying to reach you for urgent basis requirement from our client. If you are interested then revert back with Updated Resume to move the further step. Job Title: Validation Engineer Job Location: Puerto Rico, TX (Onsite) Job Duration: Contract Job Description: Validation, CSV, IQ, OQ ,PQ, FAT, SAT, Technical writer, documentation Experience (Years): 2-4 Essential Skills: Technical Writer & Validation Support Minimum of 3 Yr exp supporting the validation of a major capital automation projects Technical Writing Skills 1. Writing and Editing o 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 Formatting o 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 Control o Familiarity with tools like Git, SVN, or SharePoint to manage document revisions and updates. 4. Understanding of Documentation Standards o 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 Tools o Experience with tools like Confluence, MadCap Flare, or HelpNDoc for creating and managing online help systems and documentation. Validation Support Skills 1. Validation Knowledge o 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 Documentation o 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 Compliance o Knowledge of relevant regulatory standards and ensuring that validation documentation meets those requirements. 5. Cross-Functional Collaboration o 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 Desirable Skills: Management of document tracker (Actively updating the document Listing of all documents for review | approval). This includes following up with reviewers / approvers, to ensure documents are reviewed / approved on time. FAT & SAT Documentation creation. FAT & SAT Protocol and Test Plan Completed. Validation documentation creation. IQ | OQ | PQ Documentation creation. IQ | OQ | PQ Documentation Plan Completed. Action plan developed for each of the key deliverables. Support the execution of IQ, OQ & PQ Testing Must have very good written and verbal communication skills. Customer support experience preferred. Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. Employee must be able to effectively prioritize and manage multiple activities and responsibilities. Ability to function in a team environment and deliver on team objectives is required. Ability to make decisions and solve problems while exhibiting situational judgement. Bachelors Degree in Engineering, or a related technical field. Regards, Avinash Kumar (470) 462-3444 [email protected] Altitude Technology Solutions Inc. Keywords: quality analyst access management Texas Urgent Opening_____Validation Engineer____Puerto Rico, TX (Onsite) [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2124952&uid= |
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| 09:35 PM 29-Jan-25 |