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Sr. Validation Engineer

Louisville, Kentucky
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:
Provides direct technical validation engineering support of process and/or equipment upgrades, replacements, modifications and troubleshooting in the operations, manufacturing, pilot plant or capital projects. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments and process. Organizes, analyzes, and presents interpretation of results for operational issues or validation engineering projects of minor scope and complexity.

Duties/Responsibilities:
  • Update Site Validation Master Plan
  • Create qualification strategies and execute C&Q protocols
  • Owner of the qualification documentation: write, review and approve the commissioning and qualification protocols
  • Provide solutions to a variety of technical validation problems of moderate scope and complexity. 
  • Participate in validation network meetings
  • Support in all site qualification projects (CTC, Packaging, Warehouse, IS and Automation)
  • Review and approve Controlled Temperature Chambers (CTC) qualification documentation
  • Change Control owner and validation assessor
  • Support in investigations and deviations
  • Test Manager role in application Lifecycle Management system
  • Support in SOPs updates
  • Will evaluate, select and apply standard validation engineering techniques and procedures.  Assistance given for unusual problems.
  • Function as a technical validation expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex validation problems.
  • Routinely audit the validation status and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
  • Performs periodic reviews and update the periodic review forms.
  • Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
  • Work with manufacturing, maintenance, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for system modifications.
  • Work under the direct supervision of project managers to complete the validation responsibilities of engineering, and construction projects within schedule and budget constraints.
  • Generate rudimentary project cost estimates and schedules.
 
Education/Experience:
Master’s degree or bachelor’s degree in Engineering or Science 
Minimum 5 years of directly related experience.
 
Competencies/Skills:
  • Knowledge of validation processes and programs.
  • Experience working in pharmaceutical/biotech processes.
  • Documentation skills
  • 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.
  • Analytical Problem Solving.
  • Ability to handle multiple projects at one time.
  • Schedule development and basic project management.
  • Fully Bilingual (Spanish/English).
  • Excellent interpersonal skills


Ultimate Solutions USA, LLC. Is an Equal Opportunity Employer 

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