Sr. Validation Scientist (Process Validation)

Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico. 

Description: 

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. Non-Standard Shift. 

 Responsibilities: 

• 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. 
• Prompt and regular attendance to the workplace.

Competencies / Skills: 

•  Experience in validation, preferably in Process Validation.
• Experience in biotechnology, pharmaceutical or medical devices industry. 

Education: 

Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience.