Fresenius Kabi US Wilson , NC 27893
Posted 2 weeks ago
Job Summary
The Validation Specialist works to support site validation technical experts on specific project teams. The Validation Specialist will participate in the development and execution of test plans for manufacturing equipment and processes, utilities, and facilities. The incumbent will contribute as a key validation representative in support of project team activities and process design to ensure cGMP compliance and interdepartmental consistency to the site validation master plan and strategy.
Responsibilities
Prepare, review, execute, and summarize validation protocols (Installation Qualification, Operational Qualification, Performance Qualification, Investigational/Development Studies) for aseptic pharmaceutical manufacturing Use of validation metrology equipment.
Document validation plans and protocols (tests) to provide objective evidence that equipment, processes, and product meet requirements and are compliant with applicable regulations
Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention
Conduct validation testing for new products and process improvements Interact with individuals from different disciplines (Engineering, Laboratory, and Operations) to plan, execute, and complete validation activities
Ensure validation efforts are conducted in an appropriate and timely manner Perform risk assessment exercises in support of validation activities
Prepare Technical Packages and assessments for product transfers
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibility
REQUIREMENTS
AS/AA degree in related field; science, engineering, or manufacturing technology with 3+years of relevant experience
or-
BS/BA degree in related field; science, engineering, or manufacturing technology
Strong interpersonal and project management skills
Must be able to interact effectively at all levels of the company and handle confidential and sensitive information appropriately
Ability to work both independently and in partnership with others, proven ability to demonstrate leadership and use initiative and drive to achieve results
Strong conflict resolution skills
Expertise in Microsoft Office applications, including Word and Excel, and data entry experience a plus
Must be able to work multiple shifts as needed to meet deadlines
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Fresenius Kabi US