- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... risks involved in processing steps related to equipment, facility/utility and computer systems validation . This role will help develop and/or review… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… 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
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of ... goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams.… more
- J&J Family of Companies (Spring House, PA)
- …is preferred + Familiarity with bioanalytical work and workflows, instrument software, and computer systems validation in the bioanalytical space is ... for:** + the proper conduct and documentation of validations for equipment computer systems , spreadsheet validation and change control processes as well as… more
- Lilly (Concord, NC)
- …Science related field** **Previous CSQA / CSV experience** **Proficiency with GMP computer systems validation including regulations governing them** ... etc. and assure that validation artifacts follow Good Documentation Practices.** **Assure computer systems (including but not limited to IT systems , Lab… more
- Catalent Pharma Solutions (Harmans, MD)
- **Job Title:** Manager, Computer Systems Validation **City:** Harmans **State** : MD **JOB DESCRIPTION** : + Serve as the QA-CSV liaison with the ... Quality Control, IT and Validation organizations to support SaaS enterprise computer systems validation of Gene therapy like but not limited to… 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
- Integra LifeSciences (Princeton, NJ)
- …scope, budget and planning and in respect of internal processes for project computer systems validation and change control management. The requirements ... and industry best practices. + Thorough understanding of the principles of computer systems validation , SDLC methodologies and testing best practices. +… more
- J&J Family of Companies (Wilson, NC)
- …points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures ... + Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology. + Keeps systems… more
- Gilead Sciences, Inc. (Foster City, CA)
- …technical documentation and business process documentation. + Partner with quality and the computer systems validation organization to ensure validation ... quality-orientation and attention to detail and accuracy + Applied understanding of computer system validation methodology, development, and execution + Proven… 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
- BeiGene (Hopewell, NJ)
- …Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). + Demonstrated track record in ... They will be the IT Partner helping with installation, validation and maintenance of various GMP systems ...decision making. **Required Qualifications:** + Bachelor's degree in engineering, computer science or a technical degree in a related… more
- CREO (Durham, NC)
- …gathering to implementation, validation , and post-implementation support. This includes Computer Systems Validation (CSV) and, importantly, applying ... + EU Annex 11 + GAMP 5 + SDLC and custom software development + Computer Systems Validation (CSV), Computer Software Assurance (CSA) and modern … more
- Lilly (Durham, NC)
- …work irregular hours, shifts, and weekends for facility startup. + Experience maintaining Computer Systems Validation in line with pharmaceutical computer ... up as a member of the site IT organization. The Manufacturing Execution Systems (MES) Principal Engineer is responsible for the deployment of PharmaSuite MES on… more
- Lilly (Durham, NC)
- …temporarily work irregular hours, shifts, weekends for facility startup. + Experience maintaining Computer Systems Validation in line with pharmaceutical ... member of the site IT organization. The Manufacturing Execution Systems (MES) Sr Principal Systems Engineer is...a culture of compliance aligned with internal and external computer system quality standards. + Comply with the organization's… more
- ThermoFisher Scientific (Allentown, PA)
- …Validation Engineer, you will collaborate with multiple departments to support the validation of computer systems , equipment, processes, utilities, and ... and timely execution of essential activities to maintain the validation of all GxP systems . **Responsibilities** + Lead and further develop the Validation… 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 ... and release of data including data released from CM, stability, process validation , and reference standard characterization. + Utilizes technical skills to lead or… more
- Lilly (Pleasant Prairie, WI)
- …+ Previous experience with C&Q and Validation oversight including automation and computer systems validation + Demonstrated knowledge and use of US, ... the local process team or quality organization. + Approves commissioning, qualification, and validation documents for computer systems and equipment to… more
- Cognizant (Muskegon, MI)
- …engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The ... Historian, MES, ABB as well as other DCS and OT systems . **Requirements** : The Validation Lead responsibilities include: Project master validation planning… more
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