- PACIV (Indianapolis, IN)
- As a Principal Validation Engineer - CSV Program Lead, you'll drive transformative compliance and validation projects, establishing technical vision and strategy to ... and drive impactful change, the Principal Validation Engineer - CSV Program Lead position at PACIV is where your...PACIV is seeking an experienced Principal Validation Engineer - CSV Program Lead to set up and oversee … more
- Fujifilm (Thousand Oaks, CA)
- **Overview** The QA CSV Specialist will serve as technical subject matter expert for FDBC CSV process, including but not limited to GMP enterprise systems, ... records including SOPs, site deviations, CAPAs and change control records related to CSV equipment and GMP IT Applications. The role will work closely with… more
- Curia (Albuquerque, NM)
- CSV Systems Engineer III in Albuquerque, NM Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. ... Quality Management Systems and Computer System Validation efforts. Additionally, the CSV Systems Engineer III will provide guidance and expertise on various… more
- Fujifilm (Holly Springs, NC)
- …United States. **External US** **About This Role** The Senior IT Engineer 2, CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer ... System Validation ( CSV ). This role provides input and determine action items...inspections, as needed. **What You'll Do** + Ensures that CSV is conducted in a consistently high standard, within… more
- Sokol Materials & Services (Skillman, NJ)
- CSV Validation Engineer Mid-Level Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1) Job Type Validation Engineer Workspace On-site ... with at least 3 years in Computerized System Validation ( CSV ). + Experience working with QC analytical equipment (eg,...as needed. About the Role The Mid-Level Validation Engineer, CSV is responsible for supporting the successful implementation of… more
- Verista (Indianapolis, IN)
- …Expert in CSA validation principles. + Develop a strategy to convert existing CSV approaches to lab validation into a CSA documented process. + Developing, ... Management, Commercialization. + Create and revision of all IT CSV project and system deliverables including but not limited...in pharmaceutical cGxP setting with the ability to generate CSV deliverables with support of mentor. + Act as… more
- Verista (Boston, MA)
- …skills and learn from our experiences to enhance our collective expertise Senior CSV Engineer/Analyst Responsibilities: + Provide IT CSV support to implement and ... be willing to work onsite in Boston, MA + Demonstrated experience in leading CSV activities specific to Process Equipment + Proficiency using PC and Microsoft Office… more
- Verista (New Brunswick, NJ)
- …from our experiences to enhance our collective expertise Lead CSV Engineer/Analyst Responsibilities: + Authoring, editing, and executing technical commissioning, ... for automation systems including DeltaV, BMS, BAS, and EMS. + Perform CSV for production equipment and analytical instruments. + Collaborate with engineering and… more
- Lilly (Lebanon, IN)
- …of computerized systems within our active pharmaceutical ingredient manufacturing facility. The CSV Engineer will work as a member of the Process Automation team ... at Eli Lilly, Lebanon. This role will provide CSV support leading and executing CSV activities for process automation systems across the site. This role will… more
- Quality Consulting Group (Manati, PR)
- …systems. + EBRs, Laboratory Analytical instruments upgrade initiative, and CSV IT Compliance activities including development of validation documents, routing, ... execution and all related CSV Lifecycle documents. Qualifications: + Bachelor's degree in Computer...informed decision-making capability. + 5-8 years of experience in CSV + Experience in pharmaceuticals, medical devices or biopharma… more
- Fujifilm (College Station, TX)
- …representing a source of pride for the area. The Computer System Validation ( CSV ) Engineer III, under general direction, will lead the development and approval of ... + Able to work independently with minimum guidance from Sr. Engineers and/or CSV Manager (author protocol, execute, analyze data, author reports). + Must be able… more
- Fujifilm (College Station, TX)
- …lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation ( CSV ) and Lifecycle procedures with Data Integrity requirements. This ... templates, documentation, and files. + Supports regulatory and client audits as CSV subject matter expert. + Perform other duties as assigned. **Qualifications:** +… more
- Fujifilm (College Station, TX)
- …of innovation, representing a source of pride for the area. The Manager, CSV will be responsible for management, scheduling, and oversight of all GxP-Regulated ... lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation ( CSV ) and Lifecycle procedures with Data Integrity requirements at each… more
- Mentor Technical Group (Carolina, PR)
- …+ Candidates must have excellent verbal communication and technical writing skills. + Proficient in Microsoft Word, Excel, Power Point and Project. + Experience with ... all pertinent industry best practices (eg, ISPE GAMP) including development and execution of all applicable system life cycle deliverables (eg, URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ,… more
- Lilly (Indianapolis, IN)
- …quality compliance and will leverage DI principles and computer system validation ( CSV ) methods to ensure data integrity and quality by design implementing ... systems used at the IPM site. This role will consult on DI and CSV best practices, processes, service management, and risk-based quality deliverables and will have a… more
- Bristol Myers Squibb (Devens, MA)
- …to computerized systems, as well as supporting computerized system validation ( CSV ) activities. This position work closely with the Digital Plant (IT/Automation) ... investigations or change controls, deviation ownership of computerized system events, and CSV activites. + Interact with BMSDocs (Change Management System) to enter… more
- Gilead Sciences, Inc. (El Segundo, CA)
- …as Computer System Configuration Management and Computer System Validation ( CSV ), ensuring compliance with regulatory requirements, and Lifecycle procedures with ... Data Integrity requirements. This position will provide management of CSV validation activities at the El Segundo Location, as...the El Segundo Location, as well as support for ** CSV validations** **across kite network** , lead the review… more
- Insight Global (Jacksonville, FL)
- …implementation. This Manufacturing site is in the process of shifting into Maximo CSV from SAP. They will have to review existing documents, update the documents, ... . Skills and Requirements At least 5 years experience working with CSV software IQ/OQ/PQ method experience Experience working in a Manufacturing facility SAP… more
- Lilly (Lebanon, IN)
- …benchmarking of computer system validation practices. **Responsibilities:** Deliver on CSV processes: + Establish and maintain CSQ support and sustainability ... and support implementation goals. + Provide linkages to partner organizations with CSV including Automation, Site Equipment Verification, Business QA, and other CSQA… more
- Lilly (Indianapolis, IN)
- …Quality (GISQ) organization. GISQ is accountable for defining Computer System Validation ( CSV ) standards and providing thought leadership for CSV activities ... The GISQ team ensures compliance with corporate Computer System Validation ( CSV ) expectations for global computer systems, including GMP Computer systems, critical… more