Sr. Quality Engineer, Validation Job
Job Description Job Attributes+
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Job ID
9e9acccd-b162-4bf4-8a55-ed6aee5dd056
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Req #
20143742
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Job Location
7736 Zionsville Rd
Indianapolis, IN 46268, US -
Job Category
Quality
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Job Type
Regular
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Schedule
Full time
Anticipated salary range: $66,500 - $95,000
Bonus eligible: No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programsApplication window anticipated to close: 07/22/2024 *if interested in opportunity, please submit application as soon as possible.
At Cardinal Health, we're developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities.
What a Sr. Quality Engineer contributes to Cardinal Health
Schedule, execute, and evaluate scientifically and statistically sound qualification experiments complying with all regulatory requirements.Assure entire process and required inputs function in a consistent and repeatable manner, and comply with regulatory requirements, product license requirements, and policies affecting final product integrity. Coordinates schedules involving manufacturing equipment to maximize equipment utilization.Prepares documentation dossiers on completed studies that summarize the experimental results, specifications, and conformance to defined acceptance criteria.Provides technical support to various departments as needed.Develops policies, programs, SOPs, and Quality standards to meet current industry, corporate Quality, and external Regulatory requirements.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.Develops 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 operate equipment as needed to perform qualification testing.Performs other job duties as assigned.Qualifications
Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Chemistry, Metrology or related science field, or equivalent work experience preferred2 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: Experience working with radiopharmaceuticalsWhat is expected of you and others at this level
Develops processes and procedures to implement functional strategies.Role models Cardinal Health's high ethical standards and code of conduct.Builds confidence and respect of others through a positive and energizing style.Interprets internal/external business issues and adapts work priorities in own area.Strives for operational excellence by continually challenging old methods or ways of thinking and taking responsible risks to maximize results; serves as a role model in innovative thinking and in focusing on quality within work.Effectively solicits and explains difficult concepts and persuades others to adopt a point of view; states own point of view.Responsible for being a culture champion by participating in the development, monitoring and sustainment of the culture that is an integral part of the Indy manufacturing site philosophy and vision. The incumbent is responsible for embracing and demonstrating the culture of energy, passion and positive atmosphere while delivering superb customer service.Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
