- Twist BioScience (South San Francisco, CA)
- …11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ ... Sr. Director , Manufacturing Execution System (MES) (Hybrid...DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and… more
- Eisai, Inc (Nutley, NJ)
- …software applications development/support in the pharmaceutical or related industries, and system validation methodologies.Excellent technical skills in SAS ... with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills with ability to effectively… more
- Eisai, Inc (Nutley, NJ)
- …skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical...and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementation Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the ... organization. This position ensures that all global systems , electronic records, validation processes, and regulated applications meet strict regulatory… more
- Merck & Co. (Rahway, NJ)
- …clinical and commercial assembly equipment and processes for medical devices/drug delivery systems . Reporting to the Director responsible for this area, you ... develop robust assembly specifications with sound justification.Understand medical device/delivery system product design, functionality, storage, and handling requirements to… more
- Abeona (Cleveland, OH)
- …Department: Validation Reports to: Director of Validation As a Computer System Validation (CSV) Engineer in a biotechnology environment, you will ... Job Description JOB TITLE: Computer System Validation Engineer...production. Essential Duties and Responsibilities . Develop and execute validation deliverables for new and existing GxP systems… more
- Catalent Pharma Solutions (Harmans, MD)
- …and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation , USP Guidelines, ICH Guidelines, and ISPE GAMP ... **Associate Director , Validation & Engineering** Catalent Pharma...of ownership, technical excellence, and continuous improvement in equipment validation , metrology, and automation systems . + Contribute… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist...In depth understanding and knowledge of successfully validating a computer system to meet all FDA and ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… 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 ... and commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT… more
- Curia (Rensselaer, NY)
- …team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Senior CSV Systems ... functional areas across the organization to maintain and improve computer system validation processes to...experience working in a cGMP regulated industry specific to computer systems validation + … more
- Comcast (Philadelphia, PA)
- …100 miles from the office for the remote option.) **Job Summary** The Director , Access Network Architecture, Validation and Automation, will work across ... with Linux system administration. + Bachelor's degree in Engineering or Computer Science is preferred. Comcast also may consider applicants who hold some… more
- Northrop Grumman (Annapolis Junction, MD)
- …**Preferred Qualifications for Staff Systems Engineer - Verification and Validation :** + Advanced Degrees in Electrical Engineering, Computer Engineering, ... are seeking a candidate for the position of **Staff Systems Engineer - Verification and Validation (V&V)**...I&T program will adequately confirm requirement compliance + Design validation approaches to ensure the system fulfills… more
- ThermoFisher Scientific (Indianapolis, IN)
- … of critical business systems . + Coordinate all aspects of the company's Computer System Validation (CSV) and global IT activities supporting cGMP ... committed to computer systems compliance and validation.... + Integrate Risk Management tools into a compliant Computer System and Automation Validation … more
- Lilly (Pleasant Prairie, WI)
- …application of data management and integrity principles in operational processes, and Computer System Validation methodologies to ensure regulatory ... data management and integrity principles in operational processes, and Computer System Validation methodologies to...both locally and across global M&Q. Act as the Computer systems validation quality assurance… more
- BeOne Medicines (Pennington, NJ)
- …Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). Previous experience in a ... **General Description:** The Senior Director GTS Quality will be the global GTS...building, configuring, and supporting Quality Assurance and/or Quality Control systems , or Master's Degree in Engineering, Computer … more
- LifePoint Health (Beckley, WV)
- …measure data prior to data release. Develops and maintains processes for data validation and integrity for selected projects. Utilizes computer hardware and ... regarding the planning and implementation of trauma services. Reports to the Director of Emergency and Trauma Services for Raleigh General Hospital. ESSENTIAL… more
- Generac Power Systems (Waukesha, WI)
- …power. We provide a range of solutions that will work together to streamline your systems across every stage of the energy journey. Our people are united by a shared ... You will be a cultural and technical catalyst-energizing teams, optimizing systems , and delivering best-in-class solutions that power peace of mind worldwide.… more
- PCI Pharma Services (Philadelphia, PA)
- …with business units for integrated solutions. + Lead upgrades, enhancements, testing, validation , and systems performance as well as analyze software releases ... to pioneer and shape the future of PCI. **Position Summary:** The Director , Global HR/IT Applications is responsible for the strategic and operational leadership… more
- J&J Family of Companies (Raritan, NJ)
- …in accordance with J&J's Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the ... **Job Description:** Johnson and Johnson is hiring a JJTQ Director , Acquisition Divestiture in Raritan, NJ! At Johnson &...project progress and design issues + Strong experience in computer systems validation in GxP… more
- Lilly (Indianapolis, IN)
- …technical leadership across the different site and global IT groups focused on Computer System Validation Strategies, external regulations, industry best ... efficiently and within budget. **How You'll Succeed:** + Oversight of computer systems validation strategies and activities across new API facilities,… more
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