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IT Validation Specialist (Pharmaceutical Industry)

Company: datanet IT
Location: Clayton
Posted on: May 4, 2021

Job Description:

Job DescriptionOur client, a leading Danish multinational pharmaceutical company headquartered in Denmark, with production facilities in eight countries, and affiliates or offices in 5 countries is seeking an IT Validation Specialist who has experience in the following:Position Purpose:Primary responsibility is to provide/lead validation services required for the successful delivery of General, IT & Automation Projects, including New System Validation, Investigations & Deviations & Capital Projects using a home grown validation document & execution repository.ResponsibilitiesGeneral:

  • Provide validation & technical support through the validation lifecycle including: Document generation (Validation Plans, Specifications, Procedures, Validation Reports, etc.), System Assessments (System Impact, Data Integrity, Security, etc.), testing protocols (IQ, OQ, PQ, GEP), and room re-qualification with comprehensive temperature mapping.
  • Ownership of Change Requests (CRs) related to project validation responsibilities.
  • Perform compliance & technical reviews/approvals of test protocols.
  • Create new & modify existing validation procedures as required.
  • Lead validation failure investigations & support systematic problem solving to identify root cause.
  • Review & approve specifications, procedures & other required supporting documents to maintain the validated state of equipment & processes.
  • Participate in commissioning efforts for equipment, automation systems & processes & successfully transition into the ownership role for validation efforts related to the equipment, system or process.
  • Identify process improvements before equipment, systems or processes are placed under change control during validation.
  • Validation budget control/oversight & reporting on remaining PO balance.
  • Support PM with contractor scheduling & oversight, as needed.New Systems Validations:
    • Author & Manage Change Requests for Computer System Validation & room re-qualification.
    • Author Validation Documentation: Validation Plans, Specifications, System Assessments (System Impact, Security, Quality, Data Integrity), System Definitions, SOPs, User Guides, Testing Protocols (IQ, OQ, PQ, & GEP) & Reports.
    • Execute assigned test protocols & system baselines for validated systems per approved timeframes.
    • Ensure validation documentation/protocols that are authored/executed are in compliance with local, corporate & regulatory regulations.Validation Related Investigations & Deviations:
      • Lead the investigations of deviations per approved timeframes.
      • Lead project teams to help identify root causes of failures & implement corrective actions which address & eliminate potential re-occurrence of the deviations.Minimum Requirements:
        • BA/BS in Engineering, Computer Science, or applicable technical degree.
        • Minimum of seven (3) years of computer system validation or quality related discipline experience in pharmaceutical environment.
        • Minimum of one (1) year of project resource experience for small to medium sized projects with experience developing validation deliverables. .Technical/Process/Functional Knowledge:
          • Knowledgeable in the following areas:
          • Understanding of system development lifecycle including validation of computer systems, operation & maintenance & decommissioning of systems.
          • Understanding of manufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities & laboratories).
            • Expert in GxP documentation practices.
            • Proficient in basic computer skills including experience in the use of Microsoft Office.
            • Ability to independently write protocols & technical documents without supervision.
            • Excellent oral & written communication skills.
            • Demonstrated knowledge of regulatory audits & inspections.
            • Demonstrated knowledge of project teams driving deliverables, tasks & activities for computer system validation.
            • Expert in utilizing appropriate root-cause analysis tools & techniques.Company DescriptionWith over 35 years of experience providing the latest in IT solutions, datanet IT is at the forefront of the technology industry. Our record includes thousands of successful deployments, which have helped us earn a reputation for excellence. By offering the best in products, expertise and customer service, we are able to deliver reliable and cost-effective solutions that are customized to meet the needs of individual customers.From small businesses to large enterprise level corporations, our customers trust us to address their needs and rely on us for fast and reliable service. Whether they need help with professional IT services or personnel staffing, dataNet IT is the go-to source for the businesses who demand only the best.Our services are specially designed to help our clients reach new levels of success by implementing cutting-edge solutions, providing forward-thinking services and supplying highly experienced personnel. When you partner with dataNet IT, you will experience: Industry leadership that reflects the latest in technological advancements Outstanding support that results in long-term professional relationships Over three decades of experience working with other top professionals in their fields Flexible, scalable and fully customized solutions Fast response times that keep pace with businessContact us today to find out more.

Keywords: datanet IT, Raleigh , IT Validation Specialist (Pharmaceutical Industry), Healthcare , Clayton, North Carolina

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