Validation Engineer

US-NJ-Princeton
Requisition ID
2017-10072

Responsibilities

Validation Engineer.  Leads GQS projects as defined by the GQS validation lead.  This role ensures compliance with applicable regulations for computerized systems. In addition, serves as a Validation expert to support the Otsuka projects beginning with Quality Assessments and ending with formal validation documents. Project Manager must be capable of creating strong teams and providing excellent customer experience. Support internal and external audits.  Review and approve validation documentation with employee responsibility. Lead internal process improvement and efficiency built activity including near and long team vision for the group.  

  • Responsible for GQS Validation artifacts for their projects.
  • Provides guidance on Validation approach, scripts, and resolves issues encountered during projects.
  • Attend validation related meetings and ensure proper representation of GQS Validation.
  • Creates meeting minutes as appropriate.
  • Contributes to Compliance Operations audit activities so that they are fully aligned with project implementation and validation/testing activities.
  • Provides weekly reports. 
  • Partners with business an IT to achieve agreed to objectives.
  • Maintains templates to current and updated state. 
  • Reviews and provides comments on project related documents.
  • Represents the GQS Validation group in team meetings.
  • Ensures adherence to departmental policies, procedures, and standards.
  • Provides support to requests related to regulatory inspections.

Travel will be approximately 25%.

Qualifications

Required

  • Minimum of 3 years of pharmaceutical industry experience to include:.
  • Minimum of 2 years of Computerized System Validation experience
  • Minimum of 1 year of vendor management.
  • Minimum of 1 years of international or global project/initiative experience.
  • Bachelor’s degree in Computer Science or Information Technology or closely related. Demonstrable understanding of FDA part 11, Annex 11, and other regulations on Computerized Systems.
  • Working knowledge of system quality control/assurance practices.
  • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
  • Demonstrated skills in quality & compliance.
  • Support internal and external audit and corrective action programs.
  • Proven skills in providing direction to contractors and consultants.
  • Data Integrity control validation.

Skills

  • Results oriented / Innovation
  • Communication skills
  • Problem solving skills
  • Detail Oriented 
  • Initiative
  • Flexibility
  • Enthusiasm

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Overview

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016. 


All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

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