Sr. Quality Engineer, Validation

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 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

Application window anticipated to close: 05/22/2024 *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 preferred
• 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: Experience working with radiopharmaceuticals

What 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 developme