Automation Engineer

For Automation services in the Manufacturing and Engineering area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in engineering, Computer Science, Information Systems, or related field, and at least five (5) years of experience in pharmaceutical operations or manufacturing process.
• Bilingual: Spanish and English (verbal/ written)
• Shift: Willing to work irregular hours, rotating shifts, weekends, and holidays, when necessary.
• Experience in:
  • Manufacturing Operations Systems: Advanced experience with CMMS (IBM Maximo) for asset lifecycle management and MES (Emerson Syncade) for production tracking and electronic batch records.
  • Automation & Data Management:  Siemens control systems and Wonderware SCADA software.
  • Familiarity with Factory Talk Batch for recipe management.
  • Proven ability to manage real-time data and historian capabilities using OSIsoft / AVEVA PI System.
  • Manufacturing IT Infrastructure: Technical knowledge of virtualization technologies (VMware vSphere) and the management of Microsoft SQL Databases within a production environment.
  • Compliance & Regulatory Standards: Direct experience in Process Automation specifically tailored to pharmaceutical or biotechnological manufacturing.
  • Solid background in Computerized Systems Validation (CSV), ensuring systems comply with GAMP 5 and 21 CFR Part 11 requirements.

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Ensures the continued operation of all Process Equipment, including programming and ongoing maintenance in the Manufacturing and Utilities Areas.
• Provides subject matter expertise in IT/Automation during installation, configuration, integration, troubleshooting, maintenance, qualification and upgrade for new and existing computerized systems in Manufacturing and Utilities Areas (systems include and not limited to PLCs, HMI, Delta V, Factory Talk, SCADA, DCS/BAS, communication interfaces, networking, printers, report engines, databases and MES system).
• Perform software or hardware changes to automation and computerized systems by developing analysis, recommending improvements to existing processes through the use of state-of-the-art computer technology.
• Participates proactively as a team member of implementation projects for new integrated business applications and process automation, providing consulting advice in the use and management of technology.
• Collaborate with multidisciplinary teams (Manufacturing, Quality, IT, Engineering, etc.) on operational and/or project activities, including providing progress updates on assigned tasks or assessments as needed. 
• Installs, configures, troubleshoots, and maintains computerized systems in Manufacturing and Utilities Areas. These systems include (but are not limited to) PLCs, SCADA, and fourth-generation languages for interface and report development.
• Provides user training and continuous support to ensure proper use of the software applications, following established operational procedures and user support during problem-solving situations associated with systems implementation.
• Reviews and tests programs to ensure that they meet manufacturers' recommended requirements for hardware and software at the personal computer and/or host computer system level. Perform changes to applications or to their corresponding configurations to ensure software works as expected before installing it in the user environment.
• Review and evaluate proposed design changes to ensure alignment with the client's requirements, cGMP, and data integrity best practices. 
• Evaluates and closes change control requirements and documentation, assuring the validated and compliant state of the environments.
• Assist with quality events investigations, internal audits, CAPA, and standalone processes related to Manufacturing/Engineering/Laboratory computerized systems, MES-related applications, and systems.
• Provides project status using project plans and performs best efforts to achieve project milestones within the pre-established due dates. Provides alternatives and problem-solving initiatives in the event of project delays or showstoppers.
• Support the standards or strategy definition for software automation, system integration, and minimum requirements for plant automation through analysis and design/re-design of current systems and processes.
• Develops and/or reviews automation and computerized system-related procedures, including Operational, Maintenance, Security, Backup and Restore, and Disaster Recovery.
• Contact hardware or software vendors (if applicable) to report or address problems. Coordinate and implement vendor recommendations.
• Assures reported problems are resolved by implementing corrective actions, such as (but not limited to) user retraining, changes to existing SOPs, applying software or hardware fixes, and Information Resources colleagues' recommendations. These activities must comply with current applicable change control procedures.
• Completes CAPAs, standalone actions, and assessments required as part of Quality Systems and/or Reliability program related to automation and computerized systems.
• Assist in the management of Capital Appropriation Requests (CARs), the timeline of process automation projects and implementation, and support Process Automation initiatives. Provides necessary support for the Data Integrity and Cyber Security program and initiatives
• Support in the execution of the Computer System Validation (CSV) program for automated and computerized systems processes.

WHO WE ARE:

We are a Service Provider company, different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?