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Validation Specialist

Posted 21 days ago

  • Expiry Date: 13 July 2022
  • Referral: 210223@accuick.com

Job Description:

  • The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems.

Primary responsibilities include:

  • Qualification of laboratory instruments, setup of computers and instruments, troubleshooting of system related issues, and technical writing and execution.

  • Executes validation projects, system qualification, and implements industry best practices for the design and delivery of GxP computerized systems.

Required 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.

  • Ability to work independently and participate in a team.

  • Work and time management skills.

  • Working proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.

Duties and 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:

  • Bachelors degree preferred, preferably in Science or Engineering.

  • 5 years relevant work experience required.

  • An equivalent combination of education, experience and training may substitute.

Working Conditions:

  • The incumbent may be required to gown and operate in classified manufacturing environments.

  • 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.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Nitin Rao

Email ID: nitinr@askconsulting.com

Phone: 678-325-1171

Full Name: Stuti Parmar

Email ID: stutip@askconsulting.com

Phone: (678) 785-3290