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About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Validation Engineer (all genders) - (unlimited / fulltime)

Ludwigshafen am Rhein, Germany Req ID 2205509 Category Quality Assurance Division AbbVie

Purpose

Primarily responsible for providing interpretation, guidance, support for business partners regarding implementation of systems, validation, qualification, and data integrity requirements for systems in GMP-, GLP-, and GCP-regulated areas of the R&D organization.

Provide interpretation, guidance for business partners regarding validation and related regulations and guidelines (external and AbbVie internal)

Responsibilities

  • Provide strategies and hands on support to achieve and maintain data integrity compliance
  • Consult and support Business System Owners and Business SMEs with their IT software projects and goals
  • Recommend plan of action for satisfactory resolution of anticipated quality and regulatory compliance issues
  • Support business and defend AbbVie's high level validation approach during regulatory authority inspections and third-party audits 
  • Review / approve standard operating procedures for the use and administration of systems with the focus on data integrity
  • Participate in CAPA activities, provide support to event owners and Business System Owners, review and approve related records
  • Provide guidance, direction, and support to RD QA staff
  • Lead or participate on process improvement projects and assist with the development of compliance plans, strategies, processes, and procedures
  • Collaborate with Operations in the AbbVie Centers of Excellence and support implementation / revision of processes and procedures
Qualifications:
  • Bachelor’s degree in engineering, natural sciences or comparable 
  • Several years of experience in drug product development or production or validation / qualification in the pharmaceutical field
  • Minimum of 4 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification / validation, documentation, or compliance
  • Key leadership competencies to include relationship-building, ability to influence, knowledge of the business, sound judgment, conflict resolution, excellent interpersonal skills
  • Ability to provide innovative ideas to improve quality and compliance that create value, always seeking new information and insights (internal and external)
  • Strong communication capabilities and teamwork capacities, on a local and global level
  • Excellent knowledge of the English and the German language (spoken and written)
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
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