Sr. Validation Specialist - Ultimate Solutions USA

Location: Louisville, Kentucky, Puerto Rico
Date Posted: 09-07-2018
UTILITIES VALIDATION SPECIALIST
 
Description
Searching for Sr. Utilities Validation Specialist with experience in Pharmaceutical and Biotechnology Industries.  The candidate must have solid GMP and regulatory experience with expertise in utilities validations (coolers) process and equipment validations.  

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
-Interact with all levels of management and staff to manage and facilitate the validation process from inception to completion by enlisting cooperation, support and approval for identified validation projects
-Plan, schedule and organize validation projects for new and existing areas, including manufacturing processes, plant systems, cleaning and equipment
-Prepares and coordinate qualification activities
-Execute and documentation of validation activities
-Communicate with the staff and management on ways of implementing plans and recommendations
- Work with Regulatory Affairs Department to provide validation support for regulatory submissions
-Review and analyze moderately complex analytical and physical data generated from validation activities
-Write validation final reports that present, summarize and offer conclusions on the validity of the process based on the results of the analysis
-Coordinate the facility qualification program by preparing the protocols, monitoring the execution, auditing the results and assisting production in resolving any identified problems
-Recommend validation strategies, priorities and resources
-Ensure accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities
 
Skills and Specifications
-Experience with coolers validations
-Minimum of 10+years of experience
-Problem Solving
-Sense of urgency
-Detail Oriented
-Validation Documentation experience
-Technical Writing is a plus
-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
-Experience in Serialization a Plus 

Education
Bachelor in Science or Engineering
Minimum of 10 years of experience in a similar position.


 Note: Special Temporary Assignment in USA-Kentucky State
 
​Ultimate Solutions USA  is an Equal Opportunity Employer.
 
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