- 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
- 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.
- 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.
- Bachelors 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
- 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.
-
Validation Engineer
1 week ago
Integration International Inc. Indianapolis, United StatesJob Details: · Title: Senior Validation Engineer · Location: Indianapolis, IN 46221 · Duration: 09 months (Intent to convert after 90 days based on performance.) · Monday to Friday 8am to 5pm · Pharmaceutical experience required. · Job Description: · How will you make an impact ...
-
Validation Engineer
1 week ago
Integration International Inc. Indianapolis, United StatesJob Description: · The Process Validation Engineer will mentor and support in the diagnoses and resolution of software, instrument, and process problems to maintain system readiness of both packaging equipment and data historian network. · You will ensure site compliance and all ...
-
Validation Engineer
15 hours ago
Precision for Medicine Indianapolis, United StatesValidation Engineer · at Precision Medicine Group (View all jobs) · Indianapolis, Indiana, United States · Why Precision for Medicine? · Welcome to the forefront of innovation in cutting edge patient treatments We are thrilled to present an incredible opportunity to join our h ...
-
Validation Engineer
1 week ago
Integration International Inc Indianapolis, United StatesJob Details: · Title: Senior Validation Engineer · Location: Indianapolis, IN 46221 · Duration: 09 months (Intent to convert after 90 days based on performance.) · Monday to Friday 8am to 5pm · Pharmaceutical experience required. · Job Description: · How will you make an ...
-
Validation Engineer
5 days ago
Insight Global Indianapolis, United StatesInsight Global is looking for a mechanical or electrical engineer with validation experience. Any kind of HVAC experience is a plus. Will develop documentation/blueprints/designs and sequences of operation for evaluation and validation of existing and new HVAC systems. Will devel ...
-
Validation Engineer
5 days ago
Procom Indianapolis, United StatesDeviation Investigator Intro: · As a Deviation Investigator, you will play a critical role in maintaining the integrity and compliance of validation processes within a regulated environment. Your expertise in engineering, scientific, or maintenance disciplines will be pivotal in ...
-
Validation Engineer
1 week ago
Katalyst HealthCares & Life Sciences Indianapolis, United StatesResponsibilities: · Determine project scope and strategy with client groups and other stakeholders to execute small and large capital projects in a cGMP environment. · Participate in the development of the following Validation efforts: Validation Planning, Protocol Generation, ...
-
Validation Engineer
1 week ago
PACIV Indianapolis, United StatesPACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA office (Indianapolis). ...
-
Validation Engineer
1 week ago
V R Della It Services Private Limited Indianapolis, United StatesJob Title: Senior Validation Engineer · Duration: 9 Months Contract · Location: Indianapolis, IN · Shift: Monday to Friday 8am to 5pm · Description: · The Process Validation Engineer will mentor and support in the diagnoses and resolution of software, instrument, and process ...
-
Validation Engineer
6 days ago
PACIV Indianapolis, United StatesPACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA office (Indianapolis). ...
-
Validation Engineer
6 days ago
PACIV Indianapolis, United StatesPACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA office (Indianapolis). ...
-
Validation Engineer
6 days ago
Integration International Inc Indianapolis, United StatesJob Description: · The Process Validation Engineer will mentor and support in the diagnoses and resolution of software, instrument, and process problems to maintain system readiness of both packaging equipment and data historian network. · You will ensure site compliance and all ...
-
Validation Engineer
2 weeks ago
PSC Biotech Indianapolis, United StatesJob Description · PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to skyrocket our ...
-
Validation Engineer
21 hours ago
PSC Biotech Indianapolis, United StatesJob Description · Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to ...
-
Senior Validation Engineer
1 week ago
Infojini Inc Indianapolis, United StatesJob Title – Senior Validation Engineer · Location – Indianapolis, IN 46221 · Duration – 9+ months contract to hire position · Shift Hours – Mon – Fri 8AM to 5PM · How will you make an impact? · • The Process Validation Engineer will mentor and support in the diagnoses and resolut ...
-
Senior Validation Engineer
6 days ago
TekWissen ® Indianapolis, United StatesPosition: Senior Validation Engineer · Location: Indianapolis, IN · Duration: 9 Months · Job Type: Contract · Work Type: Onsite · Shift: Monday to Friday - 08:00 AM to 05:00 PM · Pay Rate: 30-35/Hourly/W2 · Overview: · TekWissen Group is a workforce management provider throug ...
-
Validation Engineer II
1 week ago
BCforward Indianapolis, United StatesAbout BCforwardBCforward began as an IT business solutions and staffing firm. Founded in 1998, BCforward has grown with our customers' needs into a full service personnel solutions organization. BCforward's headquarters are in Indianapolis, Indiana and also operates delivery cent ...
-
Senior Validation Engineer
6 days ago
Infojini Indianapolis, United StatesJob Title – Senior Validation Engineer · Location – Indianapolis, IN 46221 · Duration – 9+ months contract to hire position · Shift Hours – Mon – Fri 8AM to 5PM · How will you make an impact? · • The Process Validation Engineer will mentor and support in the diagnoses and resolu ...
-
Senior Validation Engineer
1 week ago
Infojini Indianapolis, United StatesJob Title Senior Validation Engineer · Location Indianapolis, IN 46221 · Duration 9+ months contract to hire position · Shift Hours Mon Fri 8AM to 5PM · How will you make an impact? · The Process Validation Engineer will mentor and support in the diagnoses and resolution of ...
-
Senior validation engineer
20 hours ago
Della Infotech Indianapolis, United StatesJob Title: · Senior Validation Engineer · Duration: 9 Months Contract · Location: Indianapolis, IN · Pay rate: $ 40/hr · Intent to convert after 90 days based on performance. · Pharmaceutical experience is required. · The Process Validation Engineer will mentor and support ...
Sr. Quality Engineer, Validation - Indianapolis, United States - Hispanic Technology Executive Council
Description
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.
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
Responsibilities
Qualifications
What is expected of you and others at this level
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. 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.
