Senior Validation Engineer, Quality Engineering - Providence, United States - Cardinal Health

Description

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Cardinal Health

Senior Validation Engineer, Quality Engineering

in

Providence ,

Rhode Island

The Senior Validation Engineer is responsible for supporting the validation program for Cardinal Health's Nuclear and Precision Health Solutions (NPHS) organization.

Reporting to the Manager of Validations, this position will provide guidance on validation/qualification initiatives to project teams, while also supporting day to day activities within the NPHS organization to ensure existing systems remain in a validated state.

This position will develop and review protocols for new and existing cGMP systems, including manufacturing equipment, laboratory instrumentation, and processes, across our network of manufacturing facilities.

Anticipated salary range:
$66, $95,000.00

Benefits:
Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
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
Application window anticipated to close:

05/07/2024 *if interested in opportunity, please submit application as soon as possible.
Responsibilities
Assure compliance of validated systems for GMP manufacturing facilities
Author, execute, review, and summarize commissioning and qualification protocols for GMP systems including manufacturing equipment, laboratory instruments, utilities, spreadsheets, computer systems and processes
Author user requirement specifications for new equipment
Provide general technical advice on new equipment, and modifications to existing equipment, to ensure validation/qualification status is maintained in a state of control
Provide both on-site and remote validation support to manufacturing facilities and provide technical assistance to site personnel
Ability to multi-task on multiple projects while supporting day to day validation requests from 30+ manufacturing sites
Work cross functionally within the organization to ensure a cohesive approach to validation is maintained
Stay abreast of industry trends in validation and expectations of regulatory agencies to improve the validation program
Identify and implement improvements in the validation program including procedures, protocols, reports, and systems
Qualifications
Bachelor's degree in Engineering or a Physical Science preferred
2-4 years of relevant validation experience preferred
Knowledgeable in FDA or ICH qualification preferred
Experience in Biotech, Pharmaceutical or Medical Device operations including protocol development and field execution, preferred
Experience with GMP manufacture of radio pharmaceuticals, preferred
Excellent communication and interpersonal skills
Proficient in Microsoft Office
What is expected of you and others at this level
Applies knowledge and a solid understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
Contribute to the development of policies and procedures
Works on projects of a large scope
Develops technical solutions to a wide range of issues. Solutions are innovative and consistent with organization objectives
Completes work with some oversight, receives guidance on new projects
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.

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