Description

Seeking a Senior Process Validation Specialist . Candidate must possess Regulatory Experience in the Pharmaceutical, Biotechnology or Medical Devices industry.
 
Responsibilities

• Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field; and be able to implement validation standards on a daily basis.
• Presents interpretation of results for validation engineering projects of significant scope and complexity.
• Implements validation engineering policies and procedures in accordance with regulatory requirements and company manufacturing standards that affect multiple organizational units.
• Apply knowledge of validation engineering outside of area of expertise to broad many of assignments in related fields.
• Provides the technical validation engineering support of process and equipment issues in the laboratory or manufacturing environment.
• Work with qualification activities, utilities, facilities developing requirements and recommendation for process.
• Communicate with the staff and management on ways of implementing plans and recommendations .

Skills and Qualifications

• EXPERIENCE IN PROCESS VALIDATION IS A MUST
• Basic Project Management
• Problem solving skills
• Negotiation, persuasion, facilitation and project cost development skills.
• Manage multiple tasks
• Able to work independently
• Strong oral and written communication skills.
• Fully bilingual
• Facilitates and organizes

Requirements
 
Master's Degree in Life Sciences or Engineering and 3 years of Scientific experience or Bachelor's Degree in Life Sciences or Engineering and 5 years of Scientific experience.