- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the ... risks involved in processing steps related to equipment, facility/utility and computer systems validation . This role will help develop and/or review… more
- PCI Pharma Services (Bedford, NH)
- …and database management skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems /software/equipment supporting GMP ... Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems from supporting GxP manufacturing and QC operations and… more
- Eastman (Kingsport, TN)
- … Systems across their lifecycle, ensuring adherence to regulatory standards, Computer Systems Validation (CSV), and Data Integrity requirements. ... systems . Responsibilities + Develop 21 CFR Part 11 compliant computer systems validation plans, IQ/OQ qualification test protocols, reports, and all… more
- PACIV (Indianapolis, IN)
- …and compliance standards. If you're ready to step into a leadership role in computer systems validation and drive impactful change, the Principal ... About PACIV: We are a global leader in control systems integration and regulatory compliance engineering. For over two...CSV Program Lead to set up and oversee CSV ( Computer System Validation ) deliverables for a high-impact… more
- ThermoFisher Scientific (Santa Clara, CA)
- …cGMP, GDP, and regulatory requirements for automated systems . + Expertise in Computer Systems Validation . + Outstanding attention to detail and ability ... deliverables with outstanding attention to detail. + Write, review, and complete project validation protocols for both standard and customized systems . + Lead… more
- PCI Pharma Services (Rockford, IL)
- …calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems . + Computer Validation Focus: Ability to ... and shape the future of PCI. Responsible for overall validation project ownership of limited risk project(s) under heavy... computer tasks and have some experience with computer systems considered to have an impact… more
- Lilly (Lebanon, IN)
- … in the pharmaceutical industry **Additional Preferences:** + Direct experience with Computer Systems Validation (GAMP5) and data integrity basic ... Systems Quality Assurance is responsible for oversite of computer system validation at the Eli Lilly...right-sizing validation requirements; maintaining corporate and site computer systems standards and practices; participating in… more
- Kelly Services (Deerfield, IL)
- …the work. The incumbent will own key tasks, demonstrate solid knowledge of validated systems and computer system validation , require moderate direction, give ... **Top 3-5 Must Have Non-negotiable Skills Required** 1. Experience working in Computer System Validation (CSV) Documentation; Functional and Technical 2.… more
- Curia (Albuquerque, NM)
- …of five (5) years' relevant experience working in a cGMP regulated industry specific to computer systems validation + Validation experience in a cGMP ... Quality team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the CSV Systems… more
- Bristol Myers Squibb (Princeton, NJ)
- …as a member of a team. Additionally, you will support the execution of Computer Systems Validation processes. **Desired Candidate Characteristics:** + Prior ... methodologies preferred. + Knowledge of Software Development Lifecycle (SDLC) and of computer systems validation (CSV) + Knowledge of cGXP and 21CFR Part11… more
- Gilead Sciences, Inc. (El Segundo, CA)
- …regulatory guidelines. **Responsibilities:** + Support enterprise, cross functional and local computer systems validation activities, in providing approach, ... + Evaluate proposed changes to validated computer systems and recommend level of validation activities...computer systems and recommend level of validation activities required + Review technical communications, document flow,… more
- CSL Behring (King Of Prussia, PA)
- …instruments, and interfaces in scope. + Work with the Quality Control, Global Execution Systems , Computer Systems Validation , and Information & ... **The Opportunity** The Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce… more
- Fujifilm (College Station, TX)
- …points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures ... knowledge of engineering principles. + Working knowledge and expertise in computerized systems validation . + Computer System Validation experience with… more
- Fujifilm (College Station, TX)
- …points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures ... knowledge of engineering principles. + Working knowledge and expertise in computerized systems validation . + Computer System Validation experience with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … computer system validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation documentation such as ... rare diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi... Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in partnership with Global… more
- Astellas Pharma (Sanford, NC)
- …SDMS lab systems + Knowledge of manufacturing processes, equipment qualification and computer systems validation (CSV) according to GAMP 5 principles is ... the system administration, maintenance and enhancements to facilitate changes to laboratory systems and business processes in a complex Scientific IT landscape to… more
- Lilly (Durham, NC)
- …temporarily work irregular hours, shifts, weekends for facility startup. + Experience maintaining Computer Systems Validation in line with pharmaceutical ... better for people around the world. The Manufacturing Execution Systems (MES) Sr Principal Systems Engineer is...The Manufacturing Execution Systems (MES) Sr Principal Systems Engineer is responsible for the deployment and continuous… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Specific experience with Veeva Vault products and reporting is a plus + GxP computer systems and validation experience + Knowledge of Quality Systems ... product families, materials, planned and manufactured batches/lots, suppliers/vendors, assets ( computer systems , instruments, equipment), clinical trials, etc.… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …and framework + Must have knowledge of Software Development Lifecycle (SDLC) and of computer systems validation (CSV) + Strong Project Management skills, and ... business goals and ensure the seamless integration of applications and data systems . This role involves coordinating project-related efforts across a wide range of… more
- Lilly (Indianapolis, IN)
- …in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). + Proven ability to support ... data including data released from CM (Contract Manufacturers), stability, process validation , and reference standard characterization. + Utilizes technical skills to… more