- 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
- 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
- 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
- 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
- RxCloud (San Mateo, CA)
- …deliver GMP and technical specific training, create and manage associated metrics. Perform computer and control system validation for QC analytical ... and reports for accuracy, thoroughness and relevancy to the subject matter. Serve as validation liaison during FDA and EU regulatory inspections; authorize all … more
- Charles River (Wayne, PA)
- …metrology function. Oversee and support the testing phase of equipment monitoring systems validation efforts. Oversee equipment validation efforts regarding ... environment. Experience involving active participation in metrology, equipment qualification and system validation efforts, preferably at the project management… more
- Catapult (Princeton, NJ)
- … activities include Facility/Clean rooms, manufacturing equipment, laboratory instrument, computer system , cleaning, and manufacturing processes in an ... such as but not limited to URS, Risk Assessment, System impact assessment, Validation master plan, in...validation . Assess impact to validated status of new systems and changes to existing systems using… 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
- Accupac (Lakewood, NJ)
- …reports Update and manage the Validation Master List within the central computer system Support client audits and new project discussions as a representative ... hands-on validation experience in a regulated environment Strong understanding of FDA validation requirements and cGMP practices Excellent written and verbal… more
- Boston Scientific (St. Paul, MN)
- …(CAPA). Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls. ... will serve as quality lead in maintaining the design, development, verification, validation , and maintenance throughout the Product Life Cycle Process. At Boston… more
- Planet Pharma (Princeton, NJ)
- …formatting/document-level publishing (eg, Acrobat, DXC Toolbox, authoring templates). *Understanding of computer system validation principles and change ... needed, work with system business owners, IT, and QA to support system . implementations and updates including execution of validation scripts. Skills Must… more
- Catalent, Inc. (Chelsea, MA)
- …to GMP standards. Performs 21CFR Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements Prepares standard operating ... for new and existing control equipment Trains users on control system functionality (Programmable Logic Controller, Computer /Control Networks, Control Computers… more
- Ingersoll Rand (Salt Lake City, UT)
- …experience Master Molder 1 Certification is preferred. Thorough knowledge of ISO 13485 and FDA Quality System requirements Lean Six Sigma Green Belt or Black ... This involves supporting molding project timelines, molding process improvements and validation activities, and serving as the Flexan SLC molding Subject Matter… more
- Thermo Fisher Scientific (Plainville, MA)
- …You'll ensure the successful execution of in-process and release testing, method validation , and compliance with global regulatory standards - while shaping the ... as the site's QC lead for client audits and regulatory inspections ( FDA , EMA, Health Canada). Enable innovation : Support digital transformation initiatives… more
- Kodiak Sciences Inc (Palo Alto, CA)
- …execution and regulatory submissions. Responsibilities Support the design, development, and validation of clinical trial databases and electronic Case Report Forms ... timelines and quality standards. Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings (eg, NDA, BLA, MAA).… more
- Tekfortune (Sunnyvale, CA)
- …project team, informing them of potential risks. | Support multi-functional business systems for supply chain: Oracle EBS, Boundary system Integrations, ... and support testing activities: integration testing, SQA, user testing, validation , etc. | Support creation of training documentation and...strong IT Governance and change control process for all system changes in a FDA regulated environment… more
