Validation Engineer

in Indianapolis, IN

Validation Engineer Job

Job Description Job Attributes+

  • Job ID

    718f3c57-d57b-4ab8-94a4-b6e8b11aa618

  • Req #

    20086425

  • Job Location

    4343 W 62nd Street
    Indianapolis, IN 46268, US

  • Job Category

    Quality

  • Job Type

    Regular

  • Schedule

    Full time

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

Reports to Director, Nuclear ManufacturingThis position is responsible for schedule, execution, and evaluation of scientifically and statistically sound qualification experiments which define and demonstrate that critical Cleaning, Controls, Equipment, Facilities, Processes and Utilities, function in a consistent and repeatable manner, and are in compliance with regulatory requirements, product license restrictions, and policies affecting final product integrity.  The position schedules activities involving manufacturing equipment to maximize equipment utilization, prepares detailed, concise documentation dossiers on completed studies that summarize the experimental results, specifications, and conformance to defined acceptance criteria, provides technical support to Business Development, Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs as needed. Develops policies, programs, SOPs, and Quality standards to meet current industry, corporate Quality, and external Regulatory requirements.

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 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.

Accountabilities

Conduct Validation projects supporting a manufacturing facility and new facility start-ups.Using their knowledge of cGMPs, pharmaceutical manufacturing methods, and validations principles, this person is responsible for developing validation plans, developing/executing qualification protocols, compiling data, drafting summary reports, and reviewing validation documentation to ensure products are manufactured in accordance with appropriate regulatory agency, manufacturer and Cardinal Health specifications/requirements.Prepares scientifically sound Validation Study Protocols that incorporate the defined specifications into acceptance criteria and assessment procedures.Schedules the execution of Validation studies with the appropriate department.Prepares detailed, concise documentation dossiers on completed studies that summarize the studies experimental results and specifications and their conformance to defined acceptance criteria.Maintains close contact with Business development, Engineering, and Manufacturing groups to assure effective communication on challenges and opportunities related to validation.Provides technical support to Business Development, Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs as needed.Developing policies, programs, SOPs, and Quality standards to meet current industry, corporate Quality, and external Regulatory requirements in regards 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.Will develop and maintain re-validation schedules and validation files. Normally receives general instruction on routine work, detailed instruction on new assignments, and is able to work autonomously with very minimal supervision.He/she relies on extensive knowledge of validations standards and professional experience to develop, maintain and enforce Cardinal Health compliance standards.Must be willing to learn laboratory procedures or operate equipment as needed to perform qualification testing.Assures that all validation documentation meets or exceeds the regulatory expectations set forth by 21 CFR 210, 211, 212 , Part11, 820, ICH (Q7/8/9/10),ISPE(Commissioning and Qualification), WHO (transfer of technology), and USP (relevant chapters).Performs other job duties as assigned.

Performance Expectations

Demonstrates a commitment to the organization’s mission, vision and values supporting organizational decisions and behaviors. Contributes to the development and implementation of systems and processes ensuring strategic goal attainment.Works as part of a team with others and shows respect and values diversity toward others.Demonstrates efforts to discovering, meeting and advocating for the customer’s needs.Takes actions to continually improve quality and safety in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback.Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements.The ability to act calmly and patiently when working under pressure and/conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives.

Qualifications

Bachelor’s degree in related field (Chemical Engineering, Mechanical Engineering, Chemistry) or equivalent work experience preferredAt least 2-5 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).   Must have experience with equipment qualification, software validation, test method validation, and/or process validation.  Must understand the Validation and Technology Transfer process and have experience with writing procedures/ reports and execution of laboratory test. Must work well with others and understand how to be successful in a Team environment. 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 is a plus.

Physical/ Mental Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms;  stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

Work Environment

The primary work environment consists of a professional office and production environment within a radiopharmaceutical manufacturing facility. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

Your safety is our top priority. We regularly consult with medical professionals on best practices in COVID-19 prevention to protect our employees. We train our employees on these best practices and regularly clean our sites in accordance with CDC guidelines. Please note: All individuals entering our facilities are required to complete a self-health check, wear a mask and follow all posted guidelines

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.

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