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Validation Engineer

Puerto Rico, Puerto Rico
Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.

DESCRIPTION 

Candidates must possess an experience in the pharmaceutical and medical devices industries.  The candidate must have solid GMP and regulatory experience with expertise in equipment validations and new product transfer.

EDUCATION
  • Bachelor’s in Science or Engineering (BSME, BSEE, BSChE, BSIE preferred)
  • More than 2 years of directly related experience
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 (IQ, OQ, PQ) 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.

REQUIREMENTS/SKILLS
  • Knowledge of validation processes and programs. 
  • Experience working in pharmaceutical / biotech processes. 
  • Documentation skills is required. 
  • Ability to interpret and apply GLPs and GMPs. 
  • Able to develop solutions to routine technical problems. 
  • Validation Protocol & Report Writing. 
  • Dealing with and managing change. 
  • Technical (Equipment Specific). 
  • Analytical Problem Solving. 
  • Ability to handle multiple projects at one time. 
  • Schedule development and basic project management. 
  • Fully Bilingual (Spanish/English). 

Ultimate Solutions Corp is an Equal Opportunity Employer
 

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