Middleware Administrator - Remote / Telecommute

Middleware Administrator - Remote / Telecommute

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Responsibilities:

  • Performs validation document generation, program management, and protocol execution activities.
  • Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.
  • Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols.
  • Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
  • Protocol execution and project activities.
  • Execute qualification activities with oversight.
  • Participate in department and site project teams.
  • Perform qualification activities according to site objectives and timelines.
  • Edit department SOPs and generate basic revisions as required.
  • Execute CAPA plans, risk assessments, investigations, and root cause analysis.
  • Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
  • Defend validation protocols in internal and external audits as a subject matter expert with limited supervision.
  • Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
  • Performs general administrative and organizational activities.
  • Management of time and work deliverables, regular interface and reporting to management.
  • Complete regulatory, site, and department training requirements on a timely basis.
  • Perform other tasks as assigned.
Education and Experience:
  • Bachelor's degree preferred, preferably in Science or Engineering.
  • 8 years relevant work experience required.
  • n equivalent combination of education, experience and training may substitute.
Competencies: Knowledge, Skills, and Abilities:
  • Working understanding of validation concepts and requirements.
  • Intermediate written and verbal communication skills.
  • Knowledge of cGMP.
  • Critical reasoning and decision making skills.
  • Knowledge of validation industry and regulatory requirements.
  • bility to work independently and participate in a team.
  • Work and time management skills.
  • Working proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.
Working Conditions:
  • This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
  • The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
  • The incumbent may be required to gown and operate in classified manufacturing environments.

Read the full job description and apply online on the recuiter's web-site

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