| Sr. Validation Engineer at Remote, Remote, USA |
| Email: [email protected] |
| From: Manisha, Largeton INC [email protected] Reply to: [email protected] Hello! Hope you are doing well. I would like to share job description with you. Please review and help us to find suitable candidat e. t least 8-10 years of experience in Computer System Validation role in the pharmaceutical, biotech, medical device, or other regulated industry DemonJob Description Title- Sr. Validation Engineer Client- Pharma Location- Remote Duration-6+ Months Visa- USC, Gc Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments) Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans Providing leadership, oversight, and training related to validation activities to multi-functional teams Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentation Practices (GDP) Ensuring that the quality system elements necessary to achieve and maintain compliance across multiple businesses, including regulated environments, are established and activities related to computer systems/software testing are controlled via these elements Working with appropriate teams to establish quality expectations related to validation planning and execution Participating with stakeholders in the preparation of software specification documents, risk management and validation plans Participating in developing qualification processes and implementing standard operating procedures Participate in execution of gap assessment and remediation activities Investigate and resolve exceptions, non-conformances, deviations, CAPAs and change controls related to validation protocols Authoring, reviewing, and/or approving system change, configuration management and supporting documentation activities Preparing for and participating in external/internal computer system/software audits Serve as the SME for CSV activities and maintain knowledge and information in the CSV area of expertise Contributing to process improvements by developing and updating written procedures related to computer systems Skill competencies At least 8-10 years of experience in Computer System Validation role in the pharmaceutical, biotech, medical device, or other regulated industry Demonstrated experience in software quality assurance processes, SDLC methodology, change management, documentation, verification, and validation techniques Understanding of GAMP 5 techniques and software industry standards and their impact on internal procedures, and software quality Demonstrated project management and leadership skills Proficiency in interacting with contacts, including project teams and vendors Certified auditor or equivalent experience conducting software-vendor quality audits Working knowledge of the FDA Quality System Regulation, 21 CFR Part 11, EU GMP, Annex 11 and the European and Canadian Medical Device Directives Understanding of current software quality techniques and industry standards such as ISO, ASQ, AAMI, and GAMP Experience with the following software systems/applications: Quality Management System Document Management System Validation Management System Bachelors/Masters degree in Computer Science Engineering or equivalent Thanks, and Regards Manisha Gupta LARGETON INC. 13800 Coppermine Rd, Herndon, VA 20171 Disclaimer: Largeton is an equal opportunity employer. There is no discrimination based on race, color, religion, sex, national origin, age, disability, or any other protected status. Keywords: information technology green card Virginia Sr. Validation Engineer [email protected] |
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| Thu Apr 11 02:03:00 UTC 2024 |