- Twist BioScience (South San Francisco, CA)
- …quality standards. Oversee and execute comprehensive computer system validation ( CSV ) activities, including IQ, OQ, PQ protocols and documentation, specifically ... from a software integration perspective.Expertise in computer system validation ( CSV ) and GxP documentation practices, particularly for custom-built systems.Experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations (eg, Part 11), laws (eg, GDPR), and DS standards (eg, SDLC, CSV ).Drive continuous improvement by applying expertise in GAMP5, Good Practices Guides, and ... or Senior Management level - Required 7+ years of strong expertise in GxP regulations, CSV , 21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep… more
- Beam Therapeutics (Cambridge, MA)
- …developers, QA, and business users. Qualifications: 3-5 years of experience as an IT/ CSV Analyst or IT Project Manager, preferably in the life sciences or healthcare ... and support best practices. Familiarity with Computer Systems Validation ( CSV ) processes, including authoring and reviewing validation documentation (eg, URS,… more
- Cytiva (Miami, FL)
- …validation (PV), cleaning validation (CV) and Computer Software Validation ( CSV ) protocols and/or Plans and Reports.Assist and approve deviation investigations, ... corrective and preventative actions (CAPAs), process improvements related to equipment qualification and validation activities.Be the subject matter expert for Change Control on launched products, managing the local Change Management Board.Improve and develop… more
- EDI Staffing (Richmond, VA)
- …SQL Server, GoAnywhere MFT, data formats including ANSI X12, EDIFACT, XML, CSV , Excel. Enterprise Systems: Internal and external applications, core IT infrastructure ... and support tools. Data Engineering & Strategy: Governance, data architecture, reporting infrastructure, and machine learning readiness. Emerging Technologies: Strategic implementation of Artificial Intelligence. Serve as a technical escalation point and… more
- Ascential Technologies (San Diego, CA)
- …a regulated GxP environment. Direct, demonstrable experience with computer system validation ( CSV ) activities compliant with FDA 21 CFR Part 11, including developing ... validation documentation (protocols, reports) and managing the validation lifecycle for electronic systems. Experience managing complex data migration projects during system implementation. Experience in developing User Requirement Specifications (URS) and… more
- Tetra Tech, Inc. (Brighton, MI)
- …in Bentley OpenRoads and/or AutoCAD Civil 3D Basic knowledge of common file types: csv , txt, xml, dxf, pdf, dgn, dwg. Data entry into Microsoft Excel, Word, and ... Adobe Pro Life at Tetra Tech: The perks of working at Tetra Tech include: *Comprehensive and market-competitive benefits. *Merit-based financial rewards. *Flexibility and company-wide commitment to work/life balance. *Collaborative team atmosphere that values… more
- SGS (Irving, TX)
- …and creating excel macros Experience with PowerBi or other tool for creating reports from CSV or DB Basic knowledge of DB architecture and how to formulate SQL query ... Strong familiarity with 5G Data Performance KPIs and Call Performance KPIs Basic understanding of e911 procedure and LPP Experience troubleshooting network and device side issues. Familiar with JIRA systems Familiar with writing defect reports and providing… more
- The CERES Group (Marlborough, MA)
- …process controls including, IQ, OQ, PQ, PPQ, manufacturing equipment software ( CSV ), and TMV/MSA. *Experience in pFMEA, manufacturing process flows, control plans, ... and quality records Nice to Have Requirements *UDI and medical device labelling/marking, quality system remediation, and ability to positively interfacing with the company's suppliers. #LI-MS1 more
- North American Science Associates, Inc. (Atlanta, GA)
- …requalification and validation raw data and generate final reports. *Collaborates with CSV and IT to complete GxP documentation, compliance, and validation of ... equipment that generates electronic data compliant with industry regulations and standards (eg 21 CFR Part 11). *Investigate and troubleshoots using advanced mathematical and engineering knowledge. *Write/implement quality records such as change control plans,… more
- Cognizant Technology Solutions (Muskegon, MI)
- …*Strong understanding of GMPs, regulatory compliance, and computer system validation ( CSV ) principles. *Excellent communication skills, with the ability to influence ... stakeholders at all levels. *Experience in mentoring and developing junior engineers and technical leads. *Ability to manage multiple priorities and stakeholders in a dynamic project environment. SKILLS *Strategic thinker with a proactive and ownership-driven… more
- The Fountain Group (Manassas, VA)
- …controls Main focus is validation on equipment validation (as well as CSV , process validation, cleaning/ sterilization validation) Steam in place/ clean in place ... (SIP/ CIP) validation exp Someone who has authored IQ/OQ/PQ documents would be very helpful Degree is hard requirement Job Description: Role Purpose Develops, modifies, applies and maintains quality evaluation systems and procedures for processing materials… more
- BioSpace (Indianapolis, IN)
- …manufacturing operations. Lead and support delivery strategies, quality assessments, and CSV and C&Q verification plans. Collaborate with site automation leadership ... to integrate resources into the project team. Assist with site hiring and capability building. Collaborate with other corporate engineering groups and Lilly IT to develop delivery strategies and execution plans. Manage project delivery metrics and… more
- PACIV (San Juan, PR)
- …the Life Sciences sector, is looking for a Computerized System Validation ( CSV ) Specialist/Engineer IT Systems , for its Puerto Rico office. Job Description: ... The Computerized System Validation ( CSV ) Specialist/Engineer will be responsible for development and execution of Computerized System Validation ( CSV )… more
- Cognizant (Muskegon, MI)
- Sr/Lead CSV Specialist Cognizant Technology Solutions in LSMG is seeking for a Sr/Lead CSV Specialist who could join our team of Engineering professionals in a ... hear from you! **Job Location:** **Muskegon, MI (Onsite)** **Role Responsibilities:** The CSV Lead manages quality control checks on engineering project work. The … more
- Sanofi Group (Swiftwater, PA)
- **Job Title:** CSV Engineer **Location:** Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless ... Engineer will be responsible for ensuring all Computerized Systems Validation ( CSV ) lifecycle activities meet Sanofi's quality requirements and fulfil regulatory… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior QA Validation Specialist - CSV Systems Engineer is an integral part of the Curia ... Systems and Computer System Validation efforts. Additionally, the Senior CSV Systems Engineer will provide guidance and expertise on...provide guidance and expertise on various global and site CSV projects to ensure that quality teams have the… more
- Curia (Albuquerque, NM)
- CSV Systems Engineer III in Albuquerque, NM Build your future at Curia, where our work has the power to save lives Curia is a global contract development and ... Quality Management Systems and Computer System Validation efforts. Additionally, the CSV Systems Engineer III will provide guidance and expertise on various… more
- Lilly (Indianapolis, IN)
- …to enable the making of medicine "with safety first and quality always". The CSV Lead will provide technical leadership across the different site and global IT ... contact and has principal responsibility for supporting all internal and external CSV related audits and privacy related inspections, working in collaboration with… more
- Fujifilm (Holly Springs, NC)
- …Participates in the development of documents, processes, and procedures of the CSV program + Generates, reviews, and approves DSM Automation Computerized Systems ... and aligns with other FUJIFILM Diosynth Biotechnologies sites for CSV processes and practices + Serves as on-call support...processes and practices + Serves as on-call support for CSV Automation inquiries and troubleshooting + Other duties, as… more
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