Senior Validation Specialist

4 weeks ago


Hillsboro, United States TalentBurst Full time

Job Description:

The client requires a Subject Matter Expert in validation to support recipes and workflows and system setup/configuration for the implementation of standard Manufacturing Execution System (MES) PharmaSuite at HTO. This will enable reduced cost of ownership and harmonization of business processes between all sites using the platform.

As the Syncade platform does not align with the DP network standard, a project must be executed to transition from one MES platform to another.

Key Responsibilities:

  • Develop proficiency in the client's standard implementation of the PharmaSuite platform to enable a better understanding of how to validate a multi-environment implementation and support system configuration.
  • Develop proficiency in interfaces to the PharmaSuite platform, including warehouse management through the eWM module of SAP, SAP manufacturing, Mulesoft middleware layers, and communication to DeltaV, PI, and other manufacturing automation systems using industry-standard technologies.
  • Develop an understanding of the Core practices that need to be adopted at the site, including recipe requirement documentation, validation, project deliverables, etc.
  • Create project-specific documentation required for implementation.
  • Develop validation test scripts for all system functionality (recipes, workflows, master data).
  • Finalize and implement in test, reference, and production environments the final master data configuration.
  • Support validation activities, including authoring of test scripts, dry runs, and formal execution, as required to achieve project timelines.
  • Plan and implement project cutover solutions and support the cutover of the system including activities occurring in the manufacturing space.


  • Hillsboro, United States Harvest Technical Services Full time

    At Harvest Technical Services, we are seeking a skilled Senior Validation Specialist to support the implementation of standard Manufacturing Execution System (MES) PharmaSuite at our Hillsboro site.The successful candidate will have expertise in validation, with a focus on recipes and workflows, as well as system setup and configuration. They will work...


  • Hillsboro, United States Harvest Technical Services Full time

    Job SummaryHarvest Technical Services is seeking a highly skilled Senior Validation Specialist to support the implementation of standard Manufacturing Execution System (MES) PharmaSuite at HTO. The ideal candidate will have expertise in validation, system setup/configuration, and recipe and workflow requirement documentation.Key Responsibilities• Develop...

  • Validation Specialist

    4 weeks ago


    hillsboro, United States Planet Pharma Full time

    Main Purpose of the Position:The Validation Specialist will be accountable for supporting validation activities and validation change management system for validated equipment, utilities, and facilities such as Critical Assessment, System Impact Assessment, Requirements Trace Matrix, Data Integrity Assessment, User Requirements, and protocol generations...

  • Validation Specialist

    4 weeks ago


    hillsboro, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC Inc. - Business Excellence Professional Consulting is seeking a highly skilled Validation Specialist to join our team in Hillsboro, OR.Job Summary:We are looking for a Subject Matter Expert (SME) in the area of validation to support the implementation of standard Manufacturing Execution System (MES) PharmaSuite at HTO. The ideal candidate will have...

  • Validation Specialist

    3 weeks ago


    Hillsboro, United States Genentech Full time

    Job Description:Genentech Inc. is seeking a highly skilled Validation Specialist to support the implementation of standard Manufacturing Execution System (MES) PharmaSuite at HTO. The ideal candidate will have expertise in computerized system validation in a GMP environment and proficiency in Pharma Suite.Key Responsibilities:Develop proficiency in the Roche...


  • Hillsboro, OR, United States Genentech Full time

    Hillsboro Technical Operations (HTO) is a leading drug product and finished goods manufacturing organization. We are responsible for the reliable delivery of Roche's commercial portfolio and pipeline products.The Opportunity:In this role, you will apply knowledge of qualification and validation principles, manufacturing processes, quality systems,...


  • Hillsboro, United States Harvest Technical Services Full time

    Job SummaryHarvest Technical Services is seeking a highly skilled Senior Validation Engineer to support validation activities and validation change management system for validated equipment, utilities, and facilities. The ideal candidate will have a strong background in process engineering, validation engineering, or technical services, with a minimum of 2...


  • Hillsboro, United States Genentech Full time

    Job Summary:The Senior/Principal Quality Validation Engineer will apply knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations, and industry standards to review and approve qualification and validation documents. This role will perform quality oversight of...


  • Hillsboro, United States Synopsys Full time

    Job Summary:As a Senior Manager of Silicon Validation, you will lead a team of engineers responsible for post-silicon electrical validation and debug on mixed-signal PCIe SerDes IP. You will oversee the development of evaluation scripts, validating circuit block behavior, evaluating results, and debugging issues in an R&D test lab...

  • Validation Specialist

    4 weeks ago


    Hillsboro, United States Planet Pharma Full time

    Main Purpose of the Position:Under the direction of the PLANT Tech Transfer Validation Lead, the Validation Engineer will be accountable for supporting validation activities and validation change management system for validated equipment, utilities, and facilities such as Critical Assessment (CA), System Impact Assessment (SIA), Requirements Trace Matrix...


  • Hillsboro, United States Microsoft Corporation Full time

    Job DescriptionMicrosoft Silicon, Cloud Hardware, and Infrastructure Engineering (SCHIE) is a team that powers Microsoft's expanding Cloud Infrastructure and is responsible for delivering the core infrastructure and foundational technologies for Microsoft's over 200 online businesses. We are looking for a Senior SoC Hardware Validation Engineer to help...


  • Hillsboro, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    Position Overview:BEPC Inc. - Business Excellence Professional Consulting is seeking a skilled Validation Specialist to support our consulting team in Hillsboro, OR.Key Responsibilities:Support validation activities, including system impact assessments, requirements trace matrices, and data integrity assessments.Coordinate the collection, testing, and...


  • Hillsboro, United States BEPC Incorporated Full time

    About the Role:BEPC Incorporated is seeking a skilled Validation Specialist to support our team in Hillsboro, OR. As a Validation Engineer, you will be responsible for ensuring the validation of equipment, utilities, and facilities in a regulated environment.Main Responsibilities:Support the development, execution, and management of validation activities,...

  • Senior EHS Specialist

    4 weeks ago


    Hillsboro, Texas, United States Strivector Full time

    Job Title: Senior EHS SpecialistAbout the Role:We are seeking a highly skilled Senior EHS Specialist to join our team at Strivector. As a key member of our organization, you will be responsible for ensuring the health and safety of our employees, as well as the environmental sustainability of our operations.Key Responsibilities:* Act as an OSHA and EPA...

  • Validation Specialist

    4 weeks ago


    Hillsboro, OR, United States Harvest Technical Services, Inc. Full time

    Main Responsibilities:As a Validation Engineer at Harvest Technical Services, Inc., you will be accountable for supporting validation activities and the validation change management system for validated equipment, utilities, and facilities. Your key responsibilities will include: Developing, executing, and managing timelines for the execution of Critical...

  • Validation Specialist

    3 weeks ago


    Hillsboro, OR, United States Genentech Full time

    The PositionGenentech Inc. seeks a Subject Matter Expertise (SME) in the area of validation supporting recipes and workflows and system setup/configuration to support the implementation of standard Manufacturing Execution System (MES) PharmaSuite at HTO. This will enable reduced cost of ownership by the company, and harmonization of business processes...


  • Hillsboro, United States Avispa Technology Full time

    pAvispaTechnologyisseekingaskilledMESValidationSpecialisttosupporttheimplementationofstandardManufacturingExecutionSystem(MES)PharmaSuiteatourHillsboro,ORsite.Asakeymemberofourteam,youwillberesponsiblefordevelopingproficiencyinourstandardimplementationofthePharmaSuiteplatform,enablingsystemsetupofallmasterdata,includingmaterials,equipment,unitsofmeasure,secu...


  • Hillsboro, United States Abacus Solution Group Full time

    Job Title: Senior Semiconductor Equipment SpecialistAbout the Role:Abacus Solution Group is seeking a highly skilled Senior Semiconductor Equipment Specialist to join our team in the Hillsboro, OR area. As a key member of our team, you will be responsible for ensuring the optimal performance of our semiconductor equipment.Key Responsibilities:Interpret...


  • Hillsboro, United States Parraway Recruitment Services Full time

    Job Title: Senior Technical Support SpecialistParraway Recruitment Services is seeking a highly skilled Senior Technical Support Specialist to join our team. As a key member of our support team, you will provide technical assistance to customers on the installation, repair, and maintenance of photolithography semiconductor equipment.Key...


  • Hillsboro, United States Jacobs Full time

    Job SummaryWe are seeking a highly skilled Senior Systems Integration Specialist to join our team at Jacobs. As a key member of our engineering team, you will be responsible for designing, developing, and implementing complex systems integration solutions for our clients.Key ResponsibilitiesDesign and develop systems integration solutions for industrial...