- Insmed Incorporated (San Diego, CA)
- …hands-on experience in a validation role with responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical/Manufacturing systems ... Manage and provide oversight on multiple projects simultaneously. Coordinate and lead validation activities with internal stakeholders and project team… more
- Syner-G BioPharma Group (Boston, MA)
- …production systems , with a concentration on computerized equipment and systems validation .Report writing experience for IQ, OQ, PQ, and CSV.Knowledge, ... systems for compliance with manufacturing requirements and facility fit. Lead start-up activities, including commissioning and qualification of facilities,… more
- Cipla (Hauppauge, NY)
- …(DPI, MDI, oral solid or Injectables preferred). Technical Knowledge and Computer Systems Skills Effective interpersonal relationship skills and the ... to departmental SOPs, periodic review and reporting of the environmental monitoring system . Generate, review, approve and maintain Validation Master Plan and… more
- Merck & Co. (Durham, NC)
- …of regulatory requirements in accordance with GMP manufacturing operations.Proficiency in computer systems and applications including but not limited to:- ... (eg washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation)-Automated Systems (eg Distributed Control System (DCS), Programmable Logic… more
- Capital One (Chicago, IL)
- …ML systems Preferred Qualifications: Master's or doctoral degree in computer science, electrical engineering, mathematics, or a similar field 3+ years of ... Lead Machine Learning Engineer As a Capital One...Agile team dedicated to productionizing machine learning applications and systems at scale. You'll participate in the detailed technical… more
- ValSource, Inc. (Rahway, NJ)
- …and cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead teams of validation professionals, and provide subject… more
- Insmed Incorporated (NJ)
- …years' experience in a management validation role with responsibility for computer systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other ... but not necessarily limited to the following: Develop risk-based validation strategies for system implementation and changes...Clinical/Manufacturing systems .Project lead experience preferred.Strong experience in Clinical… more
- Capital One (New York, NY)
- Senior Lead , Machine Learning Engineer (Enterprise Platform Technology) As a Capital One Machine Learning Engineer (MLE), you'll be part of an Agile team dedicated ... to productionizing machine learning applications and systems at scale. You'll participate in the detailed technical design, development, and implementation of… more
- BioAgilytix (Durham, NC)
- …processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement ... for centralized data storage.Create APIs to enable real-time data sharing between systems , with a focus on operational efficiency and data integrity. Data Quality… more
- Insmed Incorporated (NJ)
- …seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will ... landscape and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical,… more
- Merck & Co. (Durham, NC)
- …of regulatory requirements in accordance with GMP manufacturing operations.Proficiency in computer systems and applications including but not limited to:- ... washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation)- Automated Systems (eg Distributed Control System (DCS), Programmable Logic… more
- Cipla (Reid, WI)
- …candidates with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive, and ... of approved procedures. Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory… more
- Formation Bio (New York, NY)
- …Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for ... there is a substantial component of oversight for the computer systems validation . The implementation...and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the effective review… more
- Cipla (Fall River, MA)
- …Manufacturing Practices (GMP)/Good Distribution Practices (GDP), etc. Technical Knowledge and Computer Systems Skills Understanding of machines used in ... Quality Team. The QA operation specialist (MDI) monitors and ensures validation and qualification of facility, utilities, equipment's, processes and ensure product… more
- Micron Technology, Inc. (Boise, ID)
- …Qualifications** + Internship or experience in a related field + Knowledge of computer system architecture and DRAM operation + Innovative attitude with a ... solutions that transform how the world uses information. The Systems Compatibility team ensures early validation of...for new technologies + Design and implement automation for system -level testing + Perform computer and … more
- International (Elmendorf, TX)
- …products and solutions to our customers. The Senior Engineer - HVAC, Testing and Validation will lead and execute testing activities focused on the performance, ... plans and create innovative test procedures tailored to HVAC and cooling system evaluations + Execute validation activities according to engineering standards… more
- Micron Technology, Inc. (Boise, ID)
- … validation code and measurement techniques used to evaluate systems performance, including debugging code, and aiding other engineers. Additional ... charge of Validating sophisticated DRAM products, coordinating assets, and analyzing generated validation data. The team will also write applicable validation … more
- Micron Technology, Inc. (Longmont, CO)
- …Summary:** We are seeking a highly qualified and strategic Senior Manager, SSD Product Validation Engineering to lead validation efforts across multiple SSD ... improvement in test methodologies, automation frameworks, and lab infrastructure. Team Leadership + Lead and mentor a team of validation engineers and managers.… more
- Caris Life Sciences (Irving, TX)
- …software development and validation practices comply with Caris's Computer System Validation Process. + Lead the cross-functional product development ... best practices. Guides software development project teams as a Computer Systems Validation (CSV) and...to support the development of an Off-the-shelf (OTS) computerized system .Partner with a lead auditor to ensure… more
- Lockheed Martin (Arlington, VA)
- … future technology advances in applied formal methods, simulation, test, verification, validation , and certification of autonomous and AI-enabled systems across ... new competencies for Lockheed Martin for development of Trusted-by-Design Intelligent Systems . TIL technology focus areas include Neuro-Symbolic and Generative AI,… more
