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Validation Engineer
Location:
Princeton, NJ
Description:
Validation Engineer Job Summary: The Computer System Validation (CSV) Engineer supports the new implementations and on-going enhancement of Client's computer systems related to GxP functions. This involves working with cross-functional internal and external resources, both domestically and internationally, to support corporate quality objectives involving GxP-related computer systems and to ensure compliance and quality in a regulated environment. This position supports adherence to relevant regulatory requirements, the Quality Management System (QMS) and client / company Standard Operating Procedures (SOPs) as appropriate. Responsible for authoring and reviewing CSV deliverables in a timely manner as per project plan. Primary Responsibilities Authors, and reviews and approves CSV documents. This includes, but may not be limited to, Validation Plans, User Requirement Specifications, applicable Test Scripts, Requirement Traceability Matrix, Validation Summary Reports, Configuration Specifications, or other documents as may be appropriate. Work with business users to identify and develop validation strategies for Clinical (GxP /Non-GxP) systems. Performs GxP-related activities in alignment with business requirements and ensures that they meet compliance standards as defined by the applicable regulations. Ensures evolving validation requirements are appropriately applied to Client's CSV activities. May write, contribute to or edit, as appropriate, SOPs related to the validation of GxP computer systems and/or the use or administration of the validated system(s). Applies knowledge of Cloud-based, SaaS systems, thoroughly interprets CSV regulations, guidelines and GxP practices and meets regulatory compliance and corporate business requirements. Liaises with IT and other cross-functional business teams in the development of GxP/Non-GxP deliverables, and other documentation. May assist in the management and/or oversight of other external resources for CSV-related activities. Excellent communication skills and ability to communicate information clearly and concisely to customers Willingness and ability to work with multi-functional and multi-cultural teams Strong organization, planning, and time management skills, including experience in leading and managing projects Adhere to Conexus ISMS policies Requirements 3+ years of experience in a pharmaceutical, biotechnology or related environment combined with a minimum of 2 years of experience in GxP Computer System validation or equivalent experience and/or education. Experience with R&D, Quality Veeva Vault(s) or relevant systems like TrackWise QMS, MasterControl QMS, Please Review, is a plus. Demonstrated, hands-on, applied knowledge and understanding of applicable GxP or other relevant regulatory authority regulations and guidance related to CSV (such as, GMP, GAMP, Part 11, Annex 11, etc.) activities and compliance. In-depth knowledge of relevant CFR (Title 21), Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidelines including thorough knowledge of appropriate GCP, GLP, and GMP policies and procedures. Demonstrated ability to perform computer system validation activities. Proficiency with Microsoft Office and Project Management Tools. Excellent verbal and written communication skills. Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Strong understanding of SaaS applications. Experience working with life sciences companies with at least a moderate understanding of the drug development process. Ability to work independently in a fast-paced environment
Company:
Conexus Solutions
Posted:
December 26 2023 on ApplicantPro
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More About this Listing: Validation Engineer
Validation Engineer is a Engineering Validation Engineer Job at Conexus Solutions located in Princeton NJ. Find other listings like Validation Engineer by searching Oodle for Engineering Validation Engineer Jobs.
Validation Engineer is a Engineering Validation Engineer Job at Conexus Solutions located in Princeton NJ. Find other listings like Validation Engineer by searching Oodle for Engineering Validation Engineer Jobs.