Seeking a Senior Validation Engineer that have experience in validation in new products, process and equipment validation .Candidate must possess Regulatory Experience in the Pharmaceutical, Biotechnology or Medical Devices industry.
- 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 NEW PRODUCTS INTRODUCTION
- EXPERIENCE IN MANUFACTURING PROCESS
- EXPERIENCE IN EQUIPMENT VALIDATION
- 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
Bachelor's Degree in Engineering and 2+ years of Scientific experience.
Integrated Technology and Compliance Services is an Equal Opportunity Employer