- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility ... , and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation , process validation , equipment,… more
- 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 ... DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and... (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS,… more
- BioAgilytix (Durham, NC)
- …visibility into validated data.Maintain Audit-Ready Traceability: Ensure comprehensive data-lineage and validation documentation is always ready for FDA , EMA, or ... processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement… more
- Eisai, Inc (Nutley, NJ)
- …Oracle, SQL, CDISC, and CDASH.Familiarity with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong ... software applications development/support in the pharmaceutical or related industries, and system validation methodologies.Excellent technical skills in SAS … more
- Aequor (Hicksville, OH)
- …experience in filling and packaging of pharmaceutical products. Basic knowledge of computer applications, including SHAPE system and Microsoft Office. Proficient ... upcoming batches. Sets up and monitors cleaning and filling Validation batches according to protocols. Accepts and controls labels...and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all work is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical… more
- Eisai, Inc (Nutley, NJ)
- …skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... including audit and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice (GCP) oversight, and… more
- Aequor (Cincinnati, OH)
- …Perform routine and non-routine physical and chemical testing of commercial, validation and stability samples in accordance to written methodology Analyze data ... COMPLIANCE AND QUALITY Basic knowledge and understanding of USP, cGMP, and FDA regulations Create and maintain lab record documentation (notebooks and computer… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- …standards. Requirements: 5-8 years of experience in Computer System Validation (CSV). Strong knowledge of FDA regulations and GAMP5. Hands-on experience ... Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7… more
- Barry-Wehmiller Companies (Boston, MA)
- …important goals. Responsible for developing and executing a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment. ... Us: BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize… more
- Sotera Health Services, LLC (Charlotte, NC)
- …as required to support the overall regional facility operation and quality system . Supervision Given May supervise/guide the validation departments within the ... 50% annually. Must possess a thorough understanding of US FDA Quality Systems Regulations, ISO 9000 regulations,...in document control to satisfy all ISO 13485 and FDA (or international equivalent) Quality System requirements.… more
- Katalyst HealthCares and Life Sciences (South Plainfield, NJ)
- Responsibilities: Designing and executing validation including support of computer system validation protocols to ensure consistency of data production ... Ensuring product and process development activities have all necessary validation and supporting justification. Developing technical documents utilizing a simple… more
- Barry-Wehmiller Companies (Indianapolis, IN)
- … Validation experience in the areas of automation, packaging, cleaning, Computer systems , utilities and/or facilities is desired Excellent leadership skills ... facility, and process equipment. Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment.… more
- MannKind Corporation (Danbury, CT)
- …services (Teams, SharePoint, One Drive, and other Microsoft services). Understanding of computer system validation , HIPAA and SOx regulations. Previous ... IT infrastructure including routers, firewalls, switches, servers, virtual hosts, storage systems , and other equipment. Lead IT planning for new hire onboarding,… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- …clinical trials, data integration, and programming techniques to support the creation, validation , and execution of clinical study data in a fast-paced environment ... and timely delivery of clinical trial data by performing data checks, validation , and reconciliation in line with clinical trial timelines and regulatory… more
- MSD (Gaithersburg, MD)
- …manufacturing lines through automation. Additional job duties include the configuration, validation and troubleshooting of automation system hardware and ... depending upon department requirements EXPERIENCE AND QUALIFICATIONS Bachelor's degree in Computer Science or Electrical, Mechanical, or Systems Engineering is… more
- Unifin SAS (Rochester, NY)
- …Diagrams (P&IDs) Ability to specify, procure, oversee installation, commission, and oversee validation of systems and processing equipment Strong background in ... chemical process and controls. Projects include but are not limited to manufacturing systems , sterile and non-sterile filing systems , process piping, utility … more
- GenScript/ProBio (Pennington, NJ)
- …- Equipment Qualification, Computer System Validation , SCADA system architecture, Biotech Process Equipment/ Systems . Proficient in use of electronic ... systems , including Supervisory Control and Data Acquisition (SCADA) system , PLCs, notification systems and computerized QC...( FDA , ICH, USP and EMEA guidelines) for validation of computerized equipment and automation systems ,… more
- Katalyst HealthCares and Life Sciences (Harrisburg, PA)
- …Experience with large-scale, multisite qualification projects. Knowledge of Data Integrity and Computer System Validation (CSV) principles. Certification in ... and execute commissioning protocols (FAT, SAT, IQ, OQ and PQ) for equipment, systems , and facilities. Perform system startup, debugging, and initial testing of… more
- HonorVet Technologies (Hazelwood, MO)
- …in an accurate, thorough, and timely manner. 3. Execute validation protocols associated with manufacturing/packaging equipment and procedures including revalidation ... as required to maintain systems in a validated state. 4. Provide assistance with...Diploma or GED required. 14. 1-2 years' experience in FDA regulated manufacturing environment and GMP is desired. 15.… more
