Senior Validation Engineer, Quality Engineering

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: $66,500.00 - $95,000.00

Bonus eligible: No

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

• Healthy lifestyle programs

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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