We are looking for a Senior Validations Engineer. The position is responsible for leading the validations team in the process (Solid and Liquid form) and cleaning validation programs as well as other associated activities.
Provide leadership and direction for the Site Validations Department
Provide Clear vision and direction for the Site Validations Department
Develop robust work systems/processes for the Validations Department
Maintain and improve technical skills within the department necessary to meet validation needs
Own and Execute site Cleaning & Sanitization Monitoring SOP
In conjunction with the QA department, maintain and execute the site validation master plan.
Prepare, review and approve written documents to support technical projects, regulatory submissions and coordinate the validation activities to meet critical project deadlines and and/or launch dates.
Prepare, Review and approve validation documents for products manufactured at our Greensboro, NC location.
Review documents to support technical projects and process validation activities such as investigation reports, protocols, master batch records, stability summaries, etc.
Lead various project teams such as Validation Projects, Process Improvements, or CAPA projects.
This role will also include interaction with corporate functions to ensure site compliance regarding validation approach and methodology.
This role will include interaction with Joint Venture Business partners to ensure alignment to validation processes and procedures
Assist in maintaining site regulatory compliance
Follows safety, health, and environmental policies and procedures.
Performs other duties as assigned or required by the business need.
8 to 10 years experience in Process Engineering, Process Validation, Formulation Development or related field. Pharmaceutical industry experience is a must.
Bachelors degree is required, in an Engineering field is preferred.
Must possess expert knowledge and capability in cGMP Documentation and Validations
Must possess excellent research and problem solving skills and capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
Excellent written, verbal, computer, organizational, project management and attention to detail skills required.
Significant leadership experience for a team, project and Department.
Knowledge of operating principles of laboratory or large scale equipment used in the manufacturing of liquids is preferred.
Expert knowledge of cGMP requirements.
Demonstrated professionalism and prepared to work in a team environment.
Proven self-starter capable of organizing and managing multiple projects independently in a fast paced environment.
Work hours may extend or vary across shifts depending on business needs.
Eligible to work in the United States without sponsorship