- 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 ... is hiring a Senior Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and… more
- PCI Pharma Services (Bedford, NH)
- …Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and ... electronic record and electronic signature assessments. + Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems… more
- Belcan (Indianapolis, IN)
- Computer System Validation (CSV) Program Lead Job Number: 352755 Category: -MFG & Supply Chain SBU Description: Job Title: CSV ( Computer System Validation ... #PharmaValidation #ComplianceExcellence Overview: We are seeking an experienced CSV ( Computer System Validation ) Program Lead to lead...are seeking an experienced CSV ( Computer System Validation ) Program Lead to lead the validation … more
- Kelly Services (Deerfield, IL)
- …**Top 3-5 Must Have Non-negotiable Skills Required** 1. Experience working in Computer System Validation (CSV) Documentation; Functional and Technical 2. ... will own key tasks, demonstrate solid knowledge of validated systems and computer system validation , require moderate direction, give minimal guidance to… more
- PCI Pharma Services (Rockford, IL)
- …configuration, and fundamentals of heating, air conditioning, and refrigeration systems. + Computer Validation Focus: Ability to perform complex computer ... to pioneer and shape the future of PCI. Responsible for overall validation project ownership of limited risk project(s) under heavy supervision. Responsible for… more
- Fujifilm (College Station, TX)
- …of Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems, engineering design ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- Boehringer Ingelheim (Athens, GA)
- …reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist, Validation manages all phases of higher level, more complex validation ... project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's Validation … more
- Eastman (Kingsport, TN)
- …Computerized Systems across their lifecycle, ensuring adherence to regulatory standards, Computer Systems Validation (CSV), and Data Integrity requirements. They ... systems. Responsibilities + Develop 21 CFR Part 11 compliant computer systems validation plans, IQ/OQ qualification test...21 CFR Part 11 compliant computer systems validation plans, IQ/OQ qualification test protocols, reports, and all… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the amount of system validation… more
- Catalent Pharma Solutions (Madison, WI)
- …has oversight of the validation program, including commissioning and qualification, cleaning validation , and computer system validation as well as the ... **Engineer III - Validation ** **Summary** Catalent Biologics is a fast-growing business...corrective actions. + Requires frequent sitting, standing, walking, reading, computer use, and occasional physical activities such as lifting… 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 Validation ... Engineer - CSV Program Lead to set up and oversee CSV ( Computer System Validation ) deliverables for a high-impact automation program. This role requires a… more
- Insight Global (Clayton, NC)
- …qualification and facilities commissioning activities -Strong knowledge of validation principles, including IQ/OQ/PQ protocols. -Experience with Process/Equipment/ ... Computer System Validation -Master's Degree Engineering or related field -Experience with computer system validation (CSV) and data integrity principles… more
- ThermoFisher Scientific (Greenville, NC)
- …Proven leadership experience developing teams and projects. * Strong understanding of validation principles, including equipment, process, and computer system ... Standards, Office **Job Description** **Job Summary:** The Senior Manager of QA Validation will provide oversight and manage the validation activities across… more
- Integra LifeSciences (Plainsboro, NJ)
- …or more of the following areas of validation : * Equipment Qualification * Process Validation * Cleaning validation * Computer System Validation * ... a production setting. **Responsibilities** + Generation and execution of qualification/ validation protocols including the generation, routing and approval of summary… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …of above activities performed by a vendor, as needed. + Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. + Ensure ... take charge of your future at Takeda. Join us a Manager, Clinical Data Validation Engineer in our Cambridge, MA office. At Takeda, we are transforming the… more
- PACIV (Indianapolis, IN)
- …of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. This ... Sciences, F&B and Utilities industries is looking for a full-time employed Senior Validation Engineer based at our USA office (Indianapolis) Job Description : The… more
- PACIV (Charlotte, NC)
- …Execute System Lifecycle deliverables from Commissioning and qualification (C&Q) and Computer System Validation (CSV) planning documents through System ... F&B, and Water/Wastewater clients, is looking for a full-time Validation Engineer, team member for our NC team. Job...communication skills (verbal and presentation) + Organized with strong computer literacy such as MS Word, Project, Excel, etc.… more
- ThermoFisher Scientific (Santa Clara, CA)
- …GAMP, cGMP, GDP, and regulatory requirements for automated systems. + Expertise in Computer Systems Validation . + Outstanding attention to detail and ability to ... What will you do? + Assess and define assigned validation project deliverables with outstanding attention to detail. +...attention to detail. + Write, review, and complete project validation protocols for both standard and customized systems. +… more
- Insight Global (Indianapolis, IN)
- …experience working in an environment with human safeties involved. It could be a Computer system validation process or a validation equipment process, ... Job Description Insight Global is looking for a Validation Engineer to support a large HVAC customer....will go through a series of CQV (Commission, Qualification, Validation ) within an FDA regulated environment for a pharmaceutical… more
- System One (Bellevue, WA)
- …Design Basis Accident (DBA) Without Radionuclide Release + Nuclear safety analysis computer code assessment, verification and validation The Safety Verification ... guidance in NRC's RG1.203. + Perform and coordinate safety computer code verification and validation test programs, including SETs and IETs, inside and outside… more
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