- 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
- Kelly Services (Wilmington, DE)
- **Kelly Services is actively recruiting for a Computer Systems Validation Specialist for a Long Term Contract opportunity in Newark, DE.** Qualifications: ... The official position title is Computer System Validation (CSV) specialist...(CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems .… more
- Amgen (West Greenwich, RI)
- …work alongside other innovative, driven professionals in this meaningful role. **Specialist Computer Systems Validation Engineer** **Live** **What you will ... and DTI partners for process and computer systems analysis, requirements elicitation, articulating system solutions...Amgen corporate, GxP and SOX compliance requirements + Lead computer validation testing initiates with oversight of… more
- System One (Somerset, NJ)
- …and data interpretation. + Excellent problem-solving and communication skills. + Experience with computer system validation and knowledge of GAMP 5. + ... Title: Validation Engineer IQ, OQ, PQ Hours: Mon- Fri...+ Ensure compliance with industry regulations and standards, including FDA requirements for dietary supplements and OTC products. +… 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 (Devens, MA)
- …process equipment, computer systems , manufacturing process control systems (automation) and laboratory instrumentation in an FDA regulated manufacturing ... for communicating the status of assigned projects all GMP systems maintained by Validation Engineering to all...cell therapy manufacturing facility. + Highly knowledgeable of regulatory validation requirements including FDA , EMA and all… 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 ... Engineer to represent St. Louis when globally deployed computer systems are implemented. Primary Responsibilities: +...etc.). + Competence in Medical Device Development Processes and/or Computer System Lifecycle validation compliance… more
- Eurofins (Columbia, MO)
- …in Columbia, Missouri. The Validation Specialist I will have responsibility for computer system validation activities. This will include working closely ... and remain expert on the regulatory requirements pertaining to computer systems used in the manufacture and...System support documentation, including, but not limited to, computer system validation SOPs. +… more
- Oberg Industries (Sarver, PA)
- …preferred. + Internal auditing/supplier auditing experience preferred. + Working knowledge of FDA 's Process Validation requirements and methods, (IQ, OQ, PQ) + ... Are you ready to take your validation engineering skills to the next level? Join... activities related to the production processes, equipment, and systems used in the manufacturing of our medical devices.… more
- Catalent Pharma Solutions (Bloomington, IN)
- …organizations + Understands validation technical disciplines, including equipment, cleaning, computer system validation , and process validation , ... is to manage projects relating to biopharmaceutical manufacturing equipment, critical computer systems , manufacturing processes and documentation to ensure the… 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
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …quality oversight and support for process, cleaning, shipping, computer system , equipment and instrument qualification and validation activities + ... of validation standards as they apply to facilities, utilities, equipment, computer systems , cleaning and processes. Additionally, person in this role is… more
- Bristol Myers Squibb (Bothell, WA)
- …deliverable in respect to cGMP, GDP, GXP, GAMP5 regulations, including 21CFR Part 11, computer system validation requirements, EU GMP Annex 15 principles and ... cGMP, GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU...URS, to the end of IQ/OQ/PQ and SR) and computer system validation (CSV) documents… more
- Curia (Albuquerque, NM)
- …of work for release of equipment tested. + Assist in the review of validation protocols for computer related systems , environmental monitoring, process ... facilities department to ensure proper installation and operation of systems both before and after validation . Additional...the review of changes made under the Change Control System from a validation perspective + Provide… more
- Reynolds American (Winston Salem, NC)
- …in validations, quality or regulatory compliance. + Proficient with computer systems and common terminology + Experience handling validation activities is ... and workload distribution; review deliverables for new and existing validation -relevant systems ; and perform audits of completed...+ Provide metrics for business reporting + Serve as validation project SME during FDA inspections and… 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
- ThermoFisher Scientific (Middleton, WI)
- …customer. * Executes test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably, ... on - now and in the future. Provides basic business/ system support of software systems and/or laboratory...complete performance qualification (PQ) validation . Facilitates the validation process and implementation of system upgrades,… more
- Medtronic (Lafayette, CO)
- …to lead a team of Test Engineers to develop and perform verification & validation activities for software and systems to ensure Medtronic's cutting edge medical ... and tactical execution of Test Engineering activities to support user facing validation including summative usability validation . Specific tasks include: +… more
- Integra LifeSciences (Plainsboro, NJ)
- …: * Equipment Qualification * Process Validation * Cleaning validation * Computer System Validation * Test Method Validation * Temperature ... and making headway to help improve outcomes. Qualified candidates for this **Senior Validation Engineer** must be experienced in one or more of the following areas… more
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