- 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
- 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
- Merck & Co. (Durham, NC)
- …and products needed to support manufacturing. - Operates various computer -controlled process support/process equipment Assists in troubleshooting of equipment. - ... - Completes in-process testing and inspections supporting the vaccine manufacturing, validation , and development processes as required . - Identifies and addresses… more
- Eisai, Inc (Nutley, NJ)
- …analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... all applicable worldwide regulations and guidelines (eg US, EU Directives, US FDA , PMDA, ICH). Essential Functions Independently conduct audits Review and oversee… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be able to read drawings, schematics, and isometrics. Must have basic computer skills in Microsoft Word, Excel, and PowerPoint. Must be proficient utilizing ... best industry practices, application of principles, concepts, practices, standards, validation , and qualification within a cGMP manufacturing environment.Maintains accurate… more
- Abbott (Lake Forest, IL)
- …ISO13485, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA Computer ... Specialist** **Key Responsibilities also include:** + Effectively assess regulatory and validation requirements for computer systems within organization +… more
- Kedrion Biopharma (Melville, NY)
- …the CSV guidelines and procedures. **ESSENTIAL JOB FUNCTIONS** The Computer Systems Validation Specialist is responsible for implementing FDA 21 CFR Part 11 ... standards and current industry practices. The focus of the Computer Validation Specialist role is to identify...History and Audit Trail + Conduct Data Integrity Assessments, FDA 21CFR Part11 and EU GMP Annex11 assessments +… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... is hiring a Senior Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and… more
- PCI Pharma Services (Bedford, NH)
- …Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and ... electronic record and electronic signature assessments. + Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems… more
- Abeona (Cleveland, OH)
- Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System ... laboratory, manufacturing, quality) are validated and maintained in compliance with FDA , EMA, and other global regulatory standards. This role involves close… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… more
- Catalent Pharma Solutions (Harmans, MD)
- …Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation , USP Guidelines, ICH Guidelines, and ISPE GAMP guidelines. ... **Associate Director, Validation & Engineering** Catalent Pharma Solutions is looking...of life-enhancing and life-saving treatments for patients annually. Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is… more
- Catalent Pharma Solutions (Harmans, MD)
- **Lead Specialist, QA Validation & Engineering** Catalent Pharma Solutions is looking to hire a **Lead Specialist, QA Validation & Engineering** to support our ... of life-enhancing and life-saving treatments for patients annually. Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located… more
- Novo Nordisk (Bloomington, IN)
- …and approve deviations relevant to equipment validation + Understand other validation technical disciplines, such as cleaning, computer system validation ... and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry...other validation technical disciplines, such as equipment validation , computer system validation , and… more
- Unither Pharmaceuticals (Rochester, NY)
- Validation Technician Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify ... Your role Reporting to the Quality Director, JOB SUMMARY: Assists validation efforts in many ways including the following: executes/supports equipment, cleaning,… more
- Abbott (Casa Grande, AZ)
- …(GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred. + Proficient with ... generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Validation Engineer - Casa Grande, AZ Nutrition Plant** **Working at Abbott** At… more
- Astellas Pharma (Sanford, NC)
- …coverage and flexibility may be required. **Preferred Qualifications** + Experience with computer verification/ validation . + Experience working in a clinical and ... **Specialist, QA Validation ** Do you want to be part of...Assist in the preparation and hosting of regulatory (eg FDA , EMA, DHHS, etc.) inspections as needed. **Required Qualifications**… more
- BioBridge Global (San Antonio, TX)
- …to ensure successful collaboration and equipment relocation and verification and/or validation . Professionalism and diplomacy in dealing with other Departments is ... Tasks Independently design, execute, and interpret results for laboratory experiments/ validation studies to evaluate and/or validate laboratory processes, test… more
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