Engineer

We are seeking an Engineer with experience in regulated industry to:

• Provide solutions to a variety of technical problems of moderate scope and complexity.
  
• Under general supervision, will evaluate, select and apply standard engineering techniques, basic principles and procedures.
  
• Function as a technical expert to process, equipment and/or systems during troubleshooting operations and multi-functional discussions.
  
• Frequently become actively involved in daily operations when required to meet schedules or to resolve sophisticated problems.
  
• Routinely supervise manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship. 
  
• Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for process and/or system modifications. 
  
• Support the execution of manufacturing/quality systems such as deviations, equipment qualification and/or process validation, procedures, training, and new product introductions.  
  
• Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
  
• Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity.  
  
• Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.
  
  
  

Requirements

• Masters or Bachelor’s in Engineering + 2 years of Engineering experience (Educational background in Mechanical, Electrical and/or Chemical Engineering)
  
• Experience with equipment and/or process troubleshooting in a regulated environment.
  
• Knowledge of pharmaceutical/biotech processes and GMP production operations.
  
• Organizational & technical writing skills.
  
• Proficient presentation & communication skills in English and Spanish
  
• Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.