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Validation Specialist

Job Description - Validation Specialist





  • Lead or support cross-functional teams to evaluate, develop, and manage projects for new product development and ongoing lifecycle management of products, processes, and therapies.


  • Oversee and manage operational aspects of ongoing projects, serving as a liaison between project management, planning, project teams, and line management.


  • Develop, generate, and execute equipment and process validation protocols in compliance with company and regulatory requirements.


  • Manage the development and implementation process of products and services, focusing on quality, schedule adherence, and project deliverables.


  • Review project status, budgets, and schedules; prepare status reports and updates for stakeholders.


  • Monitor project performance from initiation through completion, identifying and resolving issues to meet productivity, quality, and client-satisfaction goals.


  • Gather and manage requirements to ensure alignment with stakeholder needs and regulatory expectations.


  • Communicate effectively with stakeholders to ensure engagement and successful delivery of project objectives.


  • Maintain accurate documentation of validation activities, deviations, and reports.


  • Ensure compliance with all applicable quality, safety, and regulatory standards.


  • Other duties may be assigned.







Requirements

  • Experience: Minimum of 2 years of hands-on experience with equipment and process validation in a regulated industry (medical device, pharmaceutical, or biotechnology).

  • Technical Skills:



    • Generation and execution of validation protocols (IQ/OQ/PQ).


    • Understanding of process characterization and validation lifecycle.


    • Knowledge of statistical tools for sampling determination and process evaluation.


    • Proficiency in project management and cross-functional coordination.


  • Soft Skills: Strong analytical, organizational, and communication abilities; ability to manage multiple priorities and meet deadlines.

  • Education: Bachelor’s degree in Engineering, Life Sciences, or related field preferred.







  • Original job Validation Specialist posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.
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