Senior Quality Engineer, Validation

Cardinal Health•Indianapolis, IN

2d•$68,500 - $97,800•Onsite

About The Position

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. Accountabilities: 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.

Requirements

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.

Nice To Haves

Experience working with radiopharmaceuticals

Responsibilities

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.
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.
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.