- Colgate-Palmolive (Piscataway, NJ)
- …policies + Partner with Quality on documentation required for FDA Part 11 Computer System Validation + Manage Digital Library platform, budget, vendor ... & mitigate impact on the business process and end users + Expertise in system design, testing, implementation, FDA validation and IT agile/waterfall… 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
- Boehringer Ingelheim (Athens, GA)
- …staff and other departments. + Leads and actively supports strategic direction of validation philosophies, improve overall validation system and process flow ... effort and is responsible for assuring compliance of validated systems , process, equipment to current cGMP, FDA ,...(VMP) and Corporate Policies and Procedures. + Maintains site validation database and document systems , supports feasibility… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the ... 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
- Eastman (Kingsport, TN)
- …+ Working knowledge and expertise in computerized systems validation . + Computer System Validation experience with DCS, SAP, LIMS, etc. is preferred. ... across their lifecycle, ensuring adherence to regulatory standards, Computer Systems Validation (CSV), and...or similar discipline with 5+ Years of experience in Computer System Validation activities within… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …efforts as needed. + Act as a subject matter expert on part 11 requirements and computer system validation (CSV). + Review and approve validation ... experience is required. + Competence in Medical Device Development Processes and/or Computer System Lifecycle validation compliance demonstrated by relevant… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to...validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation… more
- Bristol Myers Squibb (Warren, NJ)
- …manufacturing computerized systems . + Strong experience writing and executing system validation & equipment qualification documents. + Ability to interact ... and change controls. **Key Responsibilities:** + Implements and maintains all validated computer systems in compliance with policies, guidelines and procedures.… more
- PCI Pharma Services (Philadelphia, PA)
- …and any applicable customer requirements are accurately incorporated into PCI systems and assures validation documentation adheres to cGMP requirements. ... but other duties may be assigned. Manage Quality Management System elements necessary to ensure appropriate characterization of the...includes strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex… more
- Catalent Pharma Solutions (Madison, WI)
- … validation program, including commissioning and qualification, cleaning validation , and computer system validation as well as the activities required ... The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as...+ Provides guidance and oversight for commissioning, qualification, and validation of simple systems and processes. +… more
- ThermoFisher Scientific (Greenville, NC)
- …validation principles, including equipment, process, and computer system validation . * Detailed knowledge of cGMP, FDA , EMA, ISO, and other regulatory ... policies in alignment with company goals and regulatory standards ( FDA , EMA, ISO, etc.). * Collaborate with cross-functional teams,... protocols (IQ, OQ, PQ) for equipment, processes, and systems . * Ensure detailed and compliant validation … 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
- PACIV (Indianapolis, IN)
- …of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System ... Sciences, F&B and Utilities industries is looking for a full-time employed Senior Validation Engineer based at our USA office (Indianapolis) Job Description : The… more
- United Therapeutics (Silver Spring, MD)
- …teams + Develop and execute protocols and summarize reports supporting the validation of equipment, systems , and processes, as needed. Participate in ... techniques for problem-solving and decision-making + Perform gap analysis of validation documentation, systems , and practices. Communicate identified gaps… more
- Danaher Corporation (Muskegon, MI)
- …experience + Familiar with Quality Systems Regulations (such as FDA 21CFR820 & 21CFR210) and International Quality System Standards (like ... or modules Life Science Manufacturing use. + Write and conduct computer /equipment system /software validations (IQ/OQ/PQ) for manufacturing processes and… more
- Novo Nordisk (Clayton, NC)
- …obtainment. Serves as a source of expertise in the group for validating new systems + Ensure compliance of validation protocols executed are aligned with local, ... us make what matters. The Position Primary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects.… more
- Abbott (Austin, TX)
- …oversight on product, process, and equipment related changes and implementations ( validation & change control). Specifically, + Provide quality support and oversight ... (approval) of process and equipment validation and change control records and activities, + Ensure...equipment (FUE) used in the support of the Quality System are validated and maintained in compliance with regulatory… more
- Integra LifeSciences (Plainsboro, NJ)
- …: * Equipment Qualification * Process Validation * Cleaning validation * Computer System Validation * Test Method Validation * Temperature ... outcomes and set new standards of care. Qualified candidates for this **Senior Validation Engineer** must be experienced in one or more of the following areas… more
- Contract Pharmacal Corp (Hauppauge, NY)
- Junior Engineer; Validation Hauppauge, NY (http://maps.google.com/maps?q=145+Oser+Avenue+Hauppauge+NY+USA+11788) Apply Description Position Summary: The Junior ... Validation Engineer (Technical Services) is responsible for performing process validation , cleaning validation and equipment validation activities for… more
- Medtronic (Lafayette, CO)
- …Engineer you will apply technical expertise to develop and perform usability and validation activities for software, hardware and systems to ensure Medtronic's ... worldwide. **A Day in the Life** + Plan and conduct user validation testing, including user recruiting, designing and conducting usability tests, summarizing,… more
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