- 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
- 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
- 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
- Philips (Cambridge, MA)
- …expertise in validation of enterprise-wide quality IT systems using established Computer System Validation (CSV) methodology + strong knowledge of working ... As a Quality Management Systems Software Validation Engineer, you will execute and manage software...Validation Engineer, you will execute and manage software validation and control activities by authoring, reviewing, and/or approving… 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
- ThermoFisher Scientific (Allentown, PA)
- … Engineer, you will collaborate with multiple departments to support the validation of computer systems, equipment, processes, utilities, and facilities ... site compliance and timely execution of essential activities to maintain the validation of all GxP systems. **Responsibilities** + Lead and further develop the… more
- Lilly (Lebanon, IN)
- …Associate - Computer Systems Quality Assurance is responsible for oversite of computer system validation at the Eli Lilly Lebanon API Manufacturing facility. ... with Automation, QC labs, and Tech@Lilly persons to develop validation strategies for the approach to computer ...develop validation strategies for the approach to computer system validation in compliance with corporate… more
- Microsoft Corporation (Hillsboro, OR)
- … Computer Science, or related field. + Applied understanding of Computer Architecture and CPU/SoC validation principles, including: Understanding of SoC ... worldwide and we are looking for a **Senior SoC Hardware (Analog/Power) Validation Engineer** to help achieve that mission. Microsoft's mission is to empower… more