Software Validation Engineer

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 .

Purpose:

Primarily responsible for completing quality assignments related to interpretation, guidance, auditing, training, and support regarding software qualification / validation and data integrity.

Responsibilities:

• Provide interpretation, guidance, and training for clients regarding software qualification / validation and related regulatory regulations / guidelines, including Data Integrity and AbbVie policies / procedures
• Support Business System Owner and Business SME with their IT software projects and goals
• Review / approve various software qualification / validation documentation, summaries, and certification packages and associated deliverables as appropriate with minimal supervision
• Provide support / participate in audits for internal computerized systems, external computerized systems, software vendors, data integrity and digital health tools. Support plan of action for satisfactory resolution of quality and regulatory compliance issues.
• Support software qualification / validation during regulatory authority inspections and third-party audits
• Support business in understanding of the process of audit responses
• Be involved in CAPA activities, provide support to event owners and Business System Owners
• Participate on process improvement projects

Qualifications

Qualifications:

• 4-year college degree (preferably BS) in Computer Science, Engineering, Chemistry, Pharmacy, Biology, or Microbiology, or equivalent experience required
• Minimum of 2 years of experience in Quality Assurance or related field such as regulated GxP environment in software qualification / validation, documentation, or compliance

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 15 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.