Senior, Quality Engineer Equipment Validation (Hybrid)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

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

Responsibilities:

• Provide interpretation and guidance regarding qualification and validation requirements in GLP-, GCP- and GMP-regulated areas of an R&D organization.
• Review / approve various qualification / validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.
• Compilation, review and approval of quality documents (Policies, Processes, Procedures, templates, formats etc.).
• Support CAPA activities related to validation and qualification
• Provide guidance, direction, and support to peers.
• Provide assurance that applicable national and international regulatory requirements are adhered to in the context of validation and qualification policies, processes, and procedures.
• Lead or participate on process improvement projects and assist with the development of compliance plans and strategies.
• Review new / updated regulations and provide comments on and assessments of how the new / updated regulations impact the organization.
• Participate in preparation and execution of authority inspections, self- inspections, vendor audits, presentation of validation concepts and system validations.
• Represent R&D QA in cross functional global expert teams, industrial and professional associations.

This role is a hybrid role with onsite in Lake County, IL. 

Qualifications

• 4 year college degree; preferably a BS in Chemistry, Biology, Engineering Pharmacy, or Microbiology.
• Minimum