Sr. Validation Specialist
Searching for Validation Engineer with experience in the pharmaceutical and medical devices industries. Candidate must possess Regulatory Experience in the Pharmaceutical, Biotechnology or Medical Devices industry.
Duties and 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
- Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards
- Generate new specifications based on new regulations required by the implementation of a new manufacturing process.
- Generates, executes, reviews, and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Prepares and coordinate qualification activities.
- Communicate with the staff and management on ways of implementing plans and recommendations.
Skills and Specifications
- Minimum of 3 years of experience
- Problem Solving
- Sense of urgency
- Detail Oriented
- Be flexible enough to travel to job sites when need arises.
- Willing to work overtime including weekend depending on the nature of work available.
- Able to work with minimum or no supervision
- Strong interpersonal skills and must work in a team
- Fully Bilingual (English and Spanish)
Bachelor in Engineering (BSME, BSEE, BSChE, BSIE preferred) or science.
Integrated Technology and Compliance Services is an Equal Opportunity Employer