- Abbott (Lake Forest, IL)
- …in ISO13485, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA ... **Key Responsibilities also include:** + Effectively assess regulatory and validation requirements for computer systems ... within organization + Identify and develop all required computer system validation deliverables including… more
- Kedrion Biopharma (Melville, NY)
- …guidelines and procedures. **ESSENTIAL JOB FUNCTIONS** The Computer Systems Validation Specialist is responsible for implementing FDA 21 CFR Part 11 ... systems within a GMP production facility. Computer System Validation Specialist is...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...In depth understanding and knowledge of successfully validating a computer system to meet all FDA ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… more
- PCI Pharma Services (Bedford, NH)
- …and guidelines (eg FDA , MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation in Biotech and/or Pharmaceutical ... with departments inside the organization to maintain and improve computer system validation processes to...skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... involved in processing steps related to equipment, facility/utility and computer systems validation . This role...to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE… more
- Abeona (Cleveland, OH)
- Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System ... through commercial production. Essential Duties and Responsibilities . Develop and execute validation deliverables for new and existing GxP systems in alignment… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part… more
- System One (Bethesda, MD)
- …or related field. + Experience in validation (equipment, process, software, or computer systems ). + Familiarity with regulatory guidelines (GxP, 21 CFR Part ... month project. Duties and Responsibilities: + Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems...strategies based on system impact. + Document validation activities following regulatory standards (eg, FDA ,… more
- Catalent Pharma Solutions (Harmans, MD)
- …and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation , USP Guidelines, ICH Guidelines, and ISPE GAMP ... a culture of ownership, technical excellence, and continuous improvement in equipment validation , metrology, and automation systems . + Contribute to site… more
- Catalent Pharma Solutions (Harmans, MD)
- …This position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the ... from the planning stage to completion in a Quality role. + Support the Computerized System Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex… more
- Novo Nordisk (Bloomington, IN)
- … validation + Understand other validation technical disciplines, such as cleaning, computer system validation , and process validation , and be able ... other validation technical disciplines, such as equipment validation , computer system validation...plans, protocols, and reports related to commissioning, qualification, and validation of simple systems and processes. This… more
- BioBridge Global (San Antonio, TX)
- …agencies or clients. Train staff on validation protocols. Manage incoming validation tickets via the ticketing system to ensure validations are assigned ... Must be familiar with the equipment maintenance system , environmental monitoring system , and ticket management systems . Must be familiar with pulling reports… more
- Unither Pharmaceuticals (Rochester, NY)
- …the Validation Document Library, maintains test equipment and documentation system . ESSENTIAL FUNCTIONS / RESPONSIBILITIES: Assists in the execution of ... products and surface swabbing for testing as outlined by validation /qualification protocols. Maintains protocols and system documentation in… more
- Curia (Albuquerque, NM)
- …equipment and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), ... validation protocols for processes, equipment, utilities, and test systems . The role also supports new product introductions, equipment...the review of changes made under the Change Control System from a validation perspective + Provide… more
- Curia (Albuquerque, NM)
- …on the GAMP V-Model Framework, as well as EU GMP Annex 11 for computer systems compliance Supervisory Responsibilities: This role does not have supervisory ... Analyst II is responsible for executing and supporting validation activities for equipment, processes, utilities, systems ,...supervision: + Small projects: 1-2 test scripts, a single system or piece of equipment, one end customer, duration… more
- Abbott (Casa Grande, AZ)
- …**What You'll Work On** + Lead and support Design Qualification processes including; System Impact Assessments (SIA), Project Validation Plan (PVP), Failure Mode ... (GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred. + Proficient with… more
- Envista Holdings Corporation (Madison, WI)
- …execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems , including software. + Prepare comprehensive validation reports and analyze ... GMP regulatory requirements highly desired + Knowledge of software validation practices for IT and automated systems ...analysis and data interpretation. + Ability to quickly learn computer business systems and software required (ie… more
- Cardinal Health (Indianapolis, IN)
- …systems including manufacturing equipment, laboratory instrumentation, utilities, spreadsheets, and computer systems . + Develop and/or review master level ... guidance to local project teams on a range of validation and qualification initiatives to ensure existing systems...or a Physical Science. + 5+ years of relevant validation experience preferred. + Knowledgeable in FDA … more
- United Therapeutics (Silver Spring, MD)
- … Datalogger Software (preferably Amphenol / Ellab) + Ability to perform validation activities for equipment, process and/or computer -related validation ... by either overseeing or else providing hands-on assistance during testing to either System Owners or Validation management + Ability to interact and communicate… more
- Bristol Myers Squibb (Devens, MA)
- …Regulatory requirements. + Familiarity with SDLC, CSV deliverables, distributed control systems and automation (GAMP) validation concepts allows this individual ... their personal lives. Read more: careers.bms.com/working-with-us . **Position: Manager, Validation Engineer, Cell Therapy** **Location: Devens, MA** **Key Responsibilities**… more
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