System Validation Engineer

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants. Job Title - Lab System ValidationLocation - West Point, PAHire Type: 11 Months+ $45/hr. on w2JD:o Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.o Experience of CSV Validation in any one of the Lab systems is must.o Should worked in pharmaceutical domain and its related knowledge is musto Good communication and technical writing skills are a musto Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.o Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.o CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred.o To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areaso Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.o Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc.o Exposure to Regulatory Audits and Remediation activitieso Ensure the CSV artefacts are in line and meets regulatory requirementso Preferred Experience in Agile Developmento Knowledge on working in Jira / Service Nowo Adaptation to AI is preferred.• Testing (in addition to above)o Experience in testing and knowledge in any one of the QC/R&D Lab systems is must.o Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must.o Knowledge on working in Jira, HP ALM or any automation testing tools.RegardsSwati SharmaTeam Lead – RecruitmentNet2Source Inc.Direct # Board # (551) 350-0021 Ext. 1142Office: 270 Davidson Ave, Suite 704, Somerset, NJ 08873LinkedIn: (4) Swati Sharma | LinkedInWebsite: www.net2source.com