Cardinal Health · 6 hours ago
Sr. Quality Engineer, Validation
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$68K/yr - $98K/yr
2+ years expCardinal Health is a healthcare services and products company, and they are seeking a Senior Quality Engineer to lead quality assurance processes at their facility. The role involves developing key suppliers to enhance raw material quality and reduce costs through improved processes and compliance with regulatory standards.
Health CareHospitalMedical
Responsibilities
Conducts & develops validation and qualification protocols, projects and studies supporting manufacturing facility start-up and operation. Validation documentation to ensure products are manufactured in accordance with cGMP, pharmaceutical regulatory agencies, manufacturer, and Cardinal Health specifications/requirements
Maintains close contact with various functions to assure effective communication on challenges and opportunities related to validation
Provides technical support as needed
Develop policies, programs, SOPs, and Quality standards to meet current industry, corporate Quality, and external Regulatory requirements regarding validation
Supports the facility in internal and external regulatory inspections
Works directly with management, contract customers, and/or contract engineers
Maintain effectiveness of the Quality System components relevant to this position
Works autonomously with minimal supervision
Develops, maintains, and enforces Cardinal Health compliance standards
Learns and carries out laboratory procedures or operating equipment as needed to perform qualification testing
Performs other job duties as assigned
Qualification
Required
2 or more years of relevant work experience as a Validation Engineer, Quality Assurance Engineering, or Quality Validation Consultant working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device)
Experience with equipment qualification, software validation, test method validation, and/or process validation
Validation and Technology Transfer process and experience with writing procedures/ reports and execution of laboratory test
Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated
Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills
Preferred
2-4 years of experience, preferred
Bachelor's degree in related field, or equivalent work experience, preferred
Preferred: Experience working with radiopharmaceuticals
Benefits
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs
Company
Cardinal Health
Cardinal Health is a manufacturer and distributor of medical and laboratory products.
10001+ employees
H1B Sponsorship
Cardinal Health 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 (128)
2024 (116)
2023 (140)
2022 (158)
2021 (106)
2020 (142)
Funding
Current Stage
Public CompanyTotal Funding
$1.08B2025-08-28Post Ipo Debt· $1B
2006-08-16Post Ipo Debt· $78M
1983-08-12IPO
Leadership Team
Aaron Alt
Chief Financial Officer
T
Tony Caprio
Executive Vice President
Recent News
Fortune
2025-12-19
GlobeNewswire
2025-12-18
vcnewsdaily.com
2025-12-17
Company data provided by crunchbase