Senior, Quality Engineer Equipment Validation

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:
To provide Quality oversight and approval for Quality Engineers on Software qualification/validation activities and documentation.

Responsibilities:
• Provide interpretation, guidance, and training for clients regarding qualification and validation and related regulatory regulations/guidelines and Corporate and GPRD site policies/procedures.
• Review/approve various qualification/validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate.
• Generate or review and provide feedback on various documents related to qualification/validation e.g. calibration, SOPs, VMPs etc.
• Be involved in CAPA activities
• 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.
• With degree - minimum of 2 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification/validation, documentation or compliance.
• Without degree - minimum of 5 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification/validation, documentation or compliance.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.