- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, ... assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification,… more
- Twist BioScience (South San Francisco, CA)
- …Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols ... (SCADA, DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and GxP documentation practices, particularly… 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 ... Microsoft Power Automate to automate high-frequency, repetitive tasks, such as data validation and QC compliance checks.Establish automated data validation and… more
- Aequor (Hicksville, OH)
- …paperwork for upcoming batches. Sets up and monitors cleaning and filling Validation batches according to protocols. Accepts and controls labels for individual ... cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe,… more
- Eisai, Inc (Nutley, NJ)
- …SQL, CDISC, and CDASH.Familiarity with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills ... of Eisai Clinical Computing Environment Support study migration, program validation , technical documentationManage J-Review set up, J-Review user access management,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical ... quality systems, or learning management systems.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well… 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
- Barry-Wehmiller Companies (Los Angeles, CA)
- …presentation skills Experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering ... management tools and word processing skills. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11… more
- Sotera Health Services, LLC (Grand Prairie, TX)
- …Homebased out of the Sterigenics facility in Grand Prairie, TX, the Regional Validation Engineer will report to the facility General Manager. Additionally, they will ... In that role, they will be responsible for helping to ensure the validation procedures and regulatory requirements are met and maintained for the America's region… more
- Katalyst HealthCares and Life Sciences (Alviso, CA)
- …equipment qualification (IQ/OQ/PQ). Development of test methods for Design V&V, Process Validation , and Production. Validation of test methods. Execution of ... Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work. Authoring/releasing of new test methods and editing/redlining of old… more
- Syner-G BioPharma Group (San Diego, CA)
- …biotech, pharmaceutical, or medical device industry. Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required. Validation expertise in ... For more information, visit www.Synergbiopharma.com POSITION OVERVIEW: We are seeking a Validation Engineer to assist with the development and execution of … more
- Katalyst HealthCares and Life Sciences (Oceanside, CA)
- …of leading and supporting successful projects. Advanced knowledge and expertise in Computer System Validation (CSV), FDA & international requirements, ... and procedures, recommending modifications to operating policies. Work closely with other validation team members to ensure system impact is assessed and mitigation… more
- MicroVention (Aliso Viejo, CA)
- …quality assurance such as design control, risk analysis, design verification, design validation , process validation , test method validation , statistical ... engineering. Work with R&D on design verification and design validation testing of new products. Work with R&D and... and data analysis. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements. Proven… more
- Beam Therapeutics (Durham, NC)
- …Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg GAMP5, FDA 21 CFR Part 11). ... Siemens BAS, and Pi. Responsibilities will include design, installation, configuration, validation , and support of existing and future implementations as we progress… more
- Novartis (Indianapolis, IN)
- …all cGMP compliance activities are followed. Participation in assigned qualification/ validation activities, and assist on deviation investigations and inspections, ... in cGMP or aseptic environment is required. Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing is highly preferred. Ability to gown… more
- New York Blood Center Inc (Rye, NY)
- …systems comply with regulatory and accreditation requirements. Reviews and approves validation studies for critical processes, equipment, and computer systems ... information, and complaints. Performs and approves consignee notification and FDA reporting of errors. Independently monitors and assesses quality performance… more
- Actalent (Cranbury, NJ)
- …you will contribute to solving problems, reviewing experimental data, writing protocols/SOPs/ validation reports, and training support staff as necessary. You will ... in-process, finished bulk, finished product, and stability products analysis in an FDA regulated lab environment. Use a variety of analytical instruments such as… more
- cGMP Consulting (Pleasant Prairie, WI)
- About Us At cGMP Consulting, we specialize in providing expert validation , qualification, and compliance services to the life sciences industry. Our team works with ... a strong understanding of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines. Responsibilities The essential functions include, but are… more
- Katalyst HealthCares and Life Sciences (Memphis, TN)
- …to solve problems related to non-routine situations. Responsible for the creation and validation of SDTM, ADaM and TLFs for CSR, ISS, and Client following's SOPs, ... for the Statistical Programmers. Develop new macros and utilities. Requirements: MS in Statistics, Computer Science or a related field with 5 to 7 years of SAS… more
- Boston Scientific (St. Paul, MN)
- …will serve as quality lead in maintaining the design, development, verification, validation , and maintenance throughout the Product Life Cycle Process. At Boston ... and regulatory requirements highly desired. Required Qualifications: Bachelor's degree in computer , electronic or electrical engineering 5+ years of experience in… more
