Job Description

Validation Specialist
Job Number: 21-13408
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Validation Specialist for our client in Princeton, NJ.
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • Responsible for the investigation of IT Enterprise related deviations to determine root cause and applicable corrective and preventive actions in accordance with FDA, MHRA and other applicable global health authority regulations.
  • Collaborate with IT and Quality resources to collect relevant information for deviation assessment and facilitate meetings with investigation teams.
  • Manage deviation records and monitor completion of corrective actions within a Quality Management System.
 
Responsibilities:
  • Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
  • Must be able to note technical attributes in potential situations or issues and process IT-based solutions across most of the job function.
  • Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
  • Must provide guidance to other employees in the interpretation of technical issues across an interdisciplinary teams.
  • Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, resource allocation, coaching other and analytical thinking.
  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. Work is self-directed.
  • Confident in making decisions for minor issues.
  • Routinely recognizes Quality issues and solves problems.
  • Proposes solutions for complex issues and works with management to resolve.
  • Follows established procedures and performs work as assigned.
  • Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
 
Qualifications:
  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
  • Ability to interpret results and situations and articulate recommendations for resolution.
  • Able to write and review reports with clarity and brevity.
  • Excellent verbal and written communication skills.
  • Advanced knowledge of complete MS Office suite. Firm understanding of technology platforms as needed for project.
  • Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management; and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)
  • Excellent oral and written communication skills.
  • B.S. degree required; advanced degree preferred.
  • Minimum 5 years Quality Assurance and/or IT experience in a pharmaceutical company
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Jay Lucas   
arjay.lucas@eclaro.com
6463571240
Jay Lucas | LinkedIn
 

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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