AbbVie · 1 hour ago
Senior Engineer, Validation
North Chicago, IL
Full-time
Onsite
Senior Level
$82K/yr - $158K/yr
5+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. The Senior Validation Engineer will lead and maintain qualification activities at the manufacturing site, ensuring compliance with regulatory requirements and internal quality standards.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Lead and execute qualification activities for facility utilities and equipment, including but not limited to temperature-controlled chambers, water for injection, clean steam, process tanks, and autoclaves
Support Factory Acceptance Testing in conjunction with Project Engineer to confirm unit is acceptable
Identify risk controls, critical elements and traceability of equipment design based on the risk assessment
Develop, review, and approve validation protocols such as URS, FRS, DQ, IQ, OQ, PQ protocols as well as summary reports
Lead and document troubleshooting efforts of issues encountered during commissioning and qualification
Ensure risk-based validation approaches following current industry guidelines (e.g., GAMP 5, ASTM E2500, ISO, FDA, EMA)
Support projects ensuring validation requirements are integrated into project deliverables and timelines are met
Coordinate with Engineering, Quality Assurance, Operations, and Maintenance to support commissioning, start-up, and qualification activities
Maintain validation status of systems through the execution of Periodic Reviews, Requalifications, and Change Controls
Maintain Validation Master Plans as appropriate. Participate in Validation Review Board meetings. Responsible for Validation Change Control documentation
Support regulatory inspections and internal audits related to equipment, utility, and facility qualification
Qualification
Required
Bachelor's Degree, a BS in an engineering discipline required
5+ years combined work experience in validation and/or engineering positions within the pharmaceutical area
Knowledge/experience in creating and executing validation documents
General understanding of pharmaceutical equipment
Preferred
Experience with clean utilities (e.g., WFI, PW, Clean Steam), facility monitoring systems, and critical environment controls
Experience in the development of commissioning, qualification, validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny
Experience in Manufacturing including 5 major validation subjects
Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing
Strong knowledge of qualification and validation lifecycle principles and applicable regulatory guidelines (FDA, EMA, ICH Q7/Q9/Q10, GAMP 5, ASTM E2500)
Sterile manufacturing qualification experience preferred
Quality System Experience such as Veeva, Trackwise, ComplianceWire
Ability to manage complex projects and multiple projects (5+) simultaneously
Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment
Hands-on experience with FUE systems and process equipment qualification
Excellent technical writing, analytical, and problem-solving skills
Experience with computerized system validation (CSV) and automation platforms
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
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
2025-12-31
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