Sr. Quality Engineer, Validation

Cardinal Health•Indianapolis, IN

22h

About The Position

What Quality Engineering contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Engineering manages product and service quality planning, evaluation and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services. Job Summary The Senior Engineer Quality Engineer leads quality assurance processes at the assigned facility. This position will be responsible for developing key suppliers to improve their processes and process capability to provide enhanced raw material supply resulting in plant cost reductions through improved raw material quality, reduced waste and inventory reductions.

Requirements

2-4 years of experience, preferred
Bachelor's degree in related 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.

Nice To Haves

Experience working with radiopharmaceuticals

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.