Sr Validation Scientist

Description

The Sr Validation Scientist will independently provides and / or directs the technical validation engineering support of process and / or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Able to troubleshoot systemic validation issues. Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and / or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity. Complete complex or novel assignments requiring development of new and / or improved validation engineering techniques and procedures. Develop validation engineering policies and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers and / or technicians on an ongoing basis as well as on a project basis. Employ advanced validation engineering techniques and / or modifications of advanced techniques within area of validation engineering expertise. Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. Work with manufacturing, process development, utilities, facilities, labs, and / or quality assurance in developing requirements and recommendations for large and / or highly complex process, system / facility modifications. Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.

Education

Doctorate degree or Master's degree and 3 years of directly related experience or

Bachelor's degree and 5 years of directly related experience.

Preferred Qualifications :

Biotechnology, Validation (Process, Cleaning, etc.), Manufacturing operations

Competencies / Skills

• Experience working with commissioning and qualification of drug substance equipment such as tanks, bioreactors, computerized systems and analytical equipment, facilities, and utilities
• In-depth knowledge of validation processes and requirements
• Interacts effectively with variety of communication and working styles
• Ability to independently determine when additional internal resources are required to solve problems
• Ability to handle multiple projects at one time
• Demonstrated Skills in the following areas :   Schedule development,  Facilitation,  Collaboration
• Basic project management
• Completion and follow-up
• Technical expertise areas of validation engineering.
• Ability to independently determine when additional external resources are required to solve problems
• Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
• Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
• Working knowledge of financial analysis tools
• Ability to delegate and manage the project work of others
• Demonstrated Skills in the following areas :   Negotiation, persuasion and facilitation,  Collaboration, Project cost development,  Conflict Resolution ,  Decision Making,  Leadership and teambuilding,  Management of contractors and vendors

Ultimate Solutions Corp is an equal opportunity employer.