Sr. Quality Engineer, Validation

About This Role

This Senior Quality Engineer will lead quality assurance processes at the assigned facility, developing and implementing policies to ensure product and service compliance with regulatory standards. The role involves conducting and developing validation and qualification protocols to support manufacturing facility operations.

Responsibilities

• Conduct & develop validation and qualification protocols, projects and studies supporting manufacturing facility start-up and operation
• Maintain close contact with various functions to assure effective communication on challenges and opportunities related to validation
• Provide technical support as needed
• Develop policies, programs, SOPs, and Quality standards to meet current industry, corporate Quality, and external Regulatory requirements regarding validation
• Support the facility in internal and external regulatory inspections
• Work 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

Requirements

• 2+ years of relevant work experience as a Validation Engineer, Quality Assurance Engineering, or Quality Validation Consultant
• Experience 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 expertise
• Experience with writing procedures/reports and execution of laboratory test
• Proficient in Microsoft Word and Microsoft Excel
• Strong technical writing skills

Qualifications

• Bachelor's degree in related field, or equivalent work experience
• 2-4 years of experience, with 2 or more years 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)

Nice to Have

• Experience working with radiopharmaceuticals

Skills

* Required skills

Benefits