SR. Validation Engineer

ITConnectUS - Foster City, CA

Role: SR. Validation Engineer (2) Location: Foster City, CA (no remote) Length: 1 year to start, likely extensions Notes: -MUST BE VERY SENIOR. -Not your run of the mill validation person, but a life long industry professional who is a Software Validation SME. -MUST have an understanding of "data integrity." Though this is a new "buzz word" and will not be in resumes, someone very senior will know what this means and should be able to explain easily -Must be hands on, not "director" or "manager" who has not been hands on recently, and has a solid understanding of data integrity (He has interviewed a few that were like this. Called themselves Director, but didn't know how to hands on validate or know what data integrity is) -Will be traveling to different partner sites with the Director to help assess the partner sites, make a plan, and then implement it as it relates to validation Description: Responsibilities: • Computer System Validation processes expert. • Maintain expertise in current and emerging GMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11). • Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule. • Lead system qualification effort and be the primary contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply. • Demonstrate expertise in system qualification and regulatory compliance and internal requirements employing regulatory guidance and industry standards. • Qualified Computer System Validation Engineer candidates must be willing to travel throughout the US for project work. Qualifications: • Bachelor’s degree in scientific or engineering discipline along with 10 plus years of experience in the field of computer validation. • Computer system validation engineer will have a Laboratory Systems Background (LIMS) and Quality Systems. Previous experience working with higher level systems. • Demonstrate expertise in system qualification and regulatory compliance and internal requirements employing regulatory guidance and industry standards. • Computer System Validation Engineers must have excellent verbal communication and technical writing skills. • Experience with all pertinent industry best practices (e.g., ISPE GAMP) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, Delta V, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report). • Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents. • Experience in Project execution within systems validation – quality systems • Ability to plan and manage own work • Computer System Validation Engineer must be willing to travel regionally and/or nationally throughout the US. Regards Jagdeep Singh Contact: (phone hidden) Ext:- 414 Email: (email hidden) Address: ITConnectUs 949 N. Cove Dr. Palatine , IL 60067 Website: www.itconnectus.com

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