AbbVie · 1 month ago
Sr. Specialist, Quality Validation
North Chicago, IL
Full-time
Onsite
Senior Level
$82K/yr - $158K/yr
6+ years expAbbVie is dedicated to discovering and delivering innovative medicines and solutions to address serious health issues. The Sr. Specialist, Quality Validation will oversee quality validation processes, manage multiple key projects, and ensure compliance with regulatory requirements in the validation engineering department.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements
Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility
Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended
Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy
Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation
May supervise contract validation resources in the timely completion of activities in his/her area of responsibility
May lead, author, or review investigations and implementation of preventive and corrective action
Qualification
Required
Bachelor's Degree Required (preferably in Biology, Chemistry or Engineering)
6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
Strong verbal and written communication skills
Solid problem solving and analytical skills
Solid interpersonal skills, including ability to negotiate/influence without authority
Ability to manage complex projects and multiple projects (5+) simultaneously
Preferred
Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
2026-01-11
2026-01-09
2026-01-09
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