Engineer-Maintenace

Ultimate Solutions • Puerto Rico, PR

21h

About The Position

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.

Requirements

• Master’s degree or bachelor’s degree in Engineering & 2 years of engineering experience.
• Experience in data analysis.
• 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

Nice To Haves

• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 11-50 employees