- Twist BioScience (South San Francisco, CA)
- …Part 11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation ( CSV ) activities, including IQ, ... DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation ( CSV...CSV ) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementation Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the ... organization. This position ensures that all global systems , electronic records, validation processes, and regulated applications meet strict regulatory… more
- Cytiva (Miami, FL)
- …(PQ), process validation (PV), cleaning validation (CV) and Computer Software Validation ( CSV ) protocols and/or Plans and Reports.Assist ... and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into...Engineer will be the subject matter expert for the validation strategy and maintain ownership of the Muskegon site… more
- JobScanner (Clarks Hill, IN)
- …or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, GAMP ... the newest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact...needs. Working closely with global and site teams, MES System Engineer will ensure compliance with validation … more
- JobScanner (Mooresville, IN)
- …or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, Strong ... the newest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact...needs. Working closely with global and site teams, MES System Engineer will ensure compliance with validation … more
- Bristol-Myers Squibb Company (Bothell, WA)
- …design through qualification (starting with URS, to the end of IQ/OQ/PQ and SR) and computer system validation ( CSV ) documents through system ... Robust knowledge of cGMP, GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and data integrity… more
- Ascential Technologies (San Diego, CA)
- …ERP is a strong plus) in a regulated GxP environment. Direct, demonstrable experience with computer system validation ( CSV ) activities compliant with FDA ... regulations. Act as the primary SME for document control and electronic system validation during internal audits and external regulatory inspections (eg,… more
- iMPact Business Group (Fort Lauderdale, FL)
- … validation activities, including test method validation (TMV) and computer system validation ( CSV ). Collaborating with cross-functional ... familiarity with test method development and validation practices. Understanding computer system validation principles in regulated industries. Having… more
- BioSpace (Tarrytown, NY)
- …solutions to maintain compliance. Applying practical experience of IT Risk Management Methodology to Computer Systems Validation ( CSV ) and Computer ... and GLP, SOX, and other compliance requirements, across all our IT systems and processes. Ensure policies, procedures, and practices maintain the highest standards… more
- Cognizant (Muskegon, MI)
- …10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible to assist Client ... that customer quality expectations are met with respect to CSV and provide guidance to the Client. Systems...MES, ABB as well as other DCS and OT systems . **Requirements** : The Validation Lead responsibilities… more
- Charles River Laboratories (Memphis, TN)
- …Owner, IT, QA, Departmental Managers, vendors, etc). * Provide guidance and support on Computer System Validation ( CSV ) practices, helping others develop ... and maintaining quality throughout. * Prepare clear and concise validation deliverables for computerized systems , including ...in the writing of SOPs as they pertain to computer system validation and data… more
- Lilly (Indianapolis, IN)
- …functions include specifying and purchasing equipment; authoring Equipment Qualification (EQ) and Computer System Validation ( CSV ) packages, managing ... support of laboratory by ensuring the equipment and associated computer systems are maintained in a qualified...Darwin (LIMS), MODA, TrackWise, and Quality Docs (EDMS). + Computer system validation experience including… more
- Bristol Myers Squibb (Summit, NJ)
- …there's no better place than here at BMS with our Cell Therapy team. The Computer Systems Validation ( CSV ) Manager supports the successful implementation ... full CSV for single and multi-user Computerized Systems . + Develops validation /qualification deliverables such as...in pharmaceutical cGMP environment. + 5 years of hands-on Computer Systems Validation experience. +… more
- Fujifilm (College Station, TX)
- …of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation ( CSV ) and Lifecycle procedures ... **Position Overview** The Manager, CSV will be responsible for management, scheduling, and...in computerized systems validation . + Computer System Validation experience with… more
- Fujifilm (College Station, TX)
- **Position Overview** The Computer System Validation ( CSV ) Engineer III, under general direction, will lead the development and approval of validation ... work independently with minimum guidance from Sr. Engineers and/or CSV Manager (author protocol, execute, analyze data, author reports)....in computerized systems validation . + Computer System Validation experience with… more
- VTI Life Sciences (San Diego, CA)
- …some of the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation ( CSV ) Specialist to be responsible for ... Test Scripts. + 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation . + Must have experience working in an… more
- Mentor Technical Group (NC)
- …development and execution of Computer System Validation ( CSV ) and Decommissioning deliverables for Laboratory Equipment/ Systems . + Acts as the ... environment is required. + Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have experience in… more
- Lilly (Indianapolis, IN)
- …for people around the world. **Responsibilities** : The Senior Director, Global Process Owner for Computer System Validation ( CSV ), as a leader within ... and maintain the global quality system for computer system validation , including Global...Systems . **Key Objectives/Deliverables** The Global Process Owner for CSV is responsible for: + Establishing and maintaining the… more
- Abeona (Cleveland, OH)
- …Engineer Department: Validation Reports to: Director of Validation As a Computer System Validation ( CSV ) Engineer in a biotechnology environment, ... through commercial production. Essential Duties and Responsibilities . Develop and execute validation deliverables for new and existing GxP systems in alignment… more
- Unither Pharmaceuticals (Rochester, NY)
- …Specifications, Functional and Design Specifications. If completed by an external company, the computer systems validation ( CSV ) specialist will be ... Computer Systems Validation Specialist... Computer Systems Validation Specialist Who we are?...In depth understanding and knowledge of successfully validating a computer system to meet all FDA and… more
