Laboratory IT Systems Specialist

Flexible & Integrated Technical ServicesBarceloneta, PR
5d

About The Position

For the IT Department/Mfg services in the Engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree with five (5) years of experience in the regulated industry. Bilingual (English & Spanish). Problem-solving and root cause analysis. Shift: Administrative and according to business needs. Experience in: Data Integrity concepts, Audit Trails, and ALCOA principles Supporting laboratory environments, ideally within a regulated (GxP) environment Laboratory equipment, qualification protocols, and software systems Troubleshooting and analytical skills related to lab IT systems Excellent writing, communication, and teamwork skills The Personality Part: Besides being an Automation Pro, you’re able to analyze data so that not a single inconsistency gets past you (which allows you to be an amazing problem-solver). You’re also a skilled multitasker with an incredible ability to set priorities. Add to this a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, and you might just be what we’re looking for! AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Attend and actively participate in project meetings, status updates, and coordination sessions with cross-functional teams, including lab Subject Matter Experts (SMEs), IT, and other stakeholders. Collaborate with laboratory SMEs and project managers in the implementation and commissioning of new laboratory equipment, ensuring proper IT integration and alignment with lab requirements. Support the development and execution of lab protocols and qualification tasks, such as equipment qualification (IQ/OQ/PQ), as instructed by the project team and in accordance with the software life cycle process. Provide hands-on support for application installations, configuration tasks, and troubleshooting for lab-related software and systems. Support setup, configuration, and ongoing maintenance of lab software applications, including instrument integration as required. Participate in the development, review, and ongoing modification of Standard Operating Procedures (SOPs), work instructions, and related documentation to reflect new processes, equipment, or system changes. Ensure compliance with IT, quality, and safety requirements for all assigned tasks. Document all work performed and maintain clear communication with the IT department and project stakeholders. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in 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?

Requirements

  • Bachelor's Degree with five (5) years of experience in the regulated industry.
  • Bilingual (English & Spanish).
  • Problem-solving and root cause analysis.
  • Experience in: Data Integrity concepts, Audit Trails, and ALCOA principles
  • Supporting laboratory environments, ideally within a regulated (GxP) environment
  • Laboratory equipment, qualification protocols, and software systems
  • Troubleshooting and analytical skills related to lab IT systems
  • Excellent writing, communication, and teamwork skills

Responsibilities

  • Attend and actively participate in project meetings, status updates, and coordination sessions with cross-functional teams, including lab Subject Matter Experts (SMEs), IT, and other stakeholders.
  • Collaborate with laboratory SMEs and project managers in the implementation and commissioning of new laboratory equipment, ensuring proper IT integration and alignment with lab requirements.
  • Support the development and execution of lab protocols and qualification tasks, such as equipment qualification (IQ/OQ/PQ), as instructed by the project team and in accordance with the software life cycle process.
  • Provide hands-on support for application installations, configuration tasks, and troubleshooting for lab-related software and systems.
  • Support setup, configuration, and ongoing maintenance of lab software applications, including instrument integration as required.
  • Participate in the development, review, and ongoing modification of Standard Operating Procedures (SOPs), work instructions, and related documentation to reflect new processes, equipment, or system changes.
  • Ensure compliance with IT, quality, and safety requirements for all assigned tasks.
  • Document all work performed and maintain clear communication with the IT department and project stakeholders.
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