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 2 decades, 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:
Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity. 

Education:
Master’s degree or bachelor’s degree in industrial engineering & 2 years of engineering experience. 


Responsibilities:

• Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements.

• Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations.

• Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization

• Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities.

• Lead the implementation of equipment improvements projects

• SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations.

• Support equipment troubleshooting within the functional area or in the scope of technical expertise.

• Support deviation process and define, Implement and own CAPAs associated to equipment within area of expertise Drives Environmental, Health and Safety compliance within the organization

Education/Experience:
Master’s degree or bachelor’s degree in Engineering & 2 years of engineering experience. 


Requirements/Skills:    

• Experience in data analysis.
• Optional knowledge of aseptic operation (filling and support).
• Recommended experience in engineering reliability elements and process excellence.
• Recommended experience in maintenance systems and asset management.
• Knowledge of pharmaceutical/biotech processes.  
• Familiarity with validation processes
• Familiarity with documentation in a highly regulated environment
• Ability to operate specialized laboratory equipment and computers. 
• Ability to interpret and apply GLPs and GMPs.  
• Ability to apply engineering science to production.  
• Demonstrated skills in problem solving and applied engineering. 
• Able to develop solutions to routine technical problems of limited scope
• Demonstrated skills in the following areas: 
  • Problem solving and applied engineering.
  • Basic technical report writing
• Verbal Communication
• Comprehensive understanding of validation protocol execution requirements
• Demonstrated skills in the following areas:
  • Basic technical presentations, personal organization
  • Validation Protocol Writing
  • Dealing with and managing change
  • Technical (Equipment Specific).
  • Analytical Problem Solving
  • Computer Literacy

Ultimate Solutions Corp is an Equal Opportunity Employer.