- Raytheon (Tucson, AZ)
- …organization to support the development, build, and verification of control actuation systems . The PCAS organization staffs mechanical engineers for a variety of ... detailed mechanical design, earned value management, test design and execution, and systems engineering. You will be expected to flex responsibilities based on the… more
- Raytheon (Tewksbury, MA)
- …will have extensive experience in testing and validating radio frequency (RF) systems and components. You will be responsible for ensuring the performance, quality, ... from you.What Will You DoDevelop and execute comprehensive test plans for RF systems and components.Perform RF testing using advanced test equipment such as spectrum… 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
- 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
- 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
- Kedrion Biopharma (Melville, NY)
- …optimization of the CSV guidelines and procedures. **ESSENTIAL JOB FUNCTIONS** The Computer Systems Validation Specialist is responsible for implementing ... and Automation systems + Ownership of all procedures related to computer systems validation + Train and mentor junior associate's in computer … 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
- 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
- Merck (West Point, PA)
- …the EMEA / AP or US region. **Primary Responsibilities:** + Delivery of best-in-class computer systems validation to capital projects. + Drive the adoption ... colleagues and coordinating activities across sites. + Ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle… more
- Lilly (Indianapolis, IN)
- …operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures and ... and experience to design, develop, implement, enhance, and maintain applicable computer systems , integration functionality and security software, specifically on… more
- Lilly (Pleasant Prairie, WI)
- …expertise to solve problems both locally and across global M&Q. Act as the Computer systems validation quality assurance project lead, working with Global ... cross-functional teams and project management experience + Demonstrated proficiency with GMP computer systems validation including regulations governing them… more
- Lilly (Durham, NC)
- …temporarily work irregular hours, shifts, weekends for facility startup. + Experience maintaining Computer Systems Validation in line with pharmaceutical ... ground up as a member of the site IT organization. The Manufacturing Execution Systems (MES) Systems Engineer is responsible for the deployment and continuous… more
- Insight Global (Raleigh, NC)
- …to their Richmond, VA, or Raleigh, NC, locations. This lead is highly skilled in Computer Systems Validation (CSV) with strong GxP experience and responsible ... guidelines (FDA 21 CFR Part 11, EU Annex 11, GxP, GAMP), a Computer Systems Validation (CSV) role, inspecting GxP's by regulating authorities, working with… 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
- 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
- Lilly (Durham, NC)
- …employment position. **Preferred attributes but not required** : + Proficiency with GMP computer systems validation including regulations governing them + ... functional areas, projects, and systems comply with corporate Computer System Validation (CSV) standards. This position is responsible for maintaining the… more
- Lilly (Indianapolis, IN)
- …OS, Oracle SQL, Microsoft SQL Server, Citrix, Kepware, ServiceNow. + Experience maintaining Computer Systems Validation in line with pharmaceutical ... enterprise architecture direction and standards. + Experience leading or supporting the Computer System Validation of IT platforms including Data Integrity… more
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