IT Systems Specialist

FITS, LLC; Manatí (PR); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Excellent customer service

Job summary

FITS, LLC is seeking an IT validation specialist for Validation services in Manufacturing Operations and Business Process areas. The role requires a BS in CS/CE/EE/IT and 5 years of IT experience in pharmaceutical manufacturing, with 3 years in process automation and 2 in computerized systems validation.

The position offers 1st shift with potential for 2nd/3rd and weekend shifts, flexible hours, and a bilingual English/Spanish requirement.

Qualifications

• Bachelor's degree in CS/CE/EE/IT with 5 years IT experience in pharma manufacturing.
• 3+ years in process automation and 2+ years in computerized systems validation.
• Bilingual: English and Spanish (verbal/written).
• Experience with validation docs per GAMP 5 and 21 CFR Part 11.

Responsibilities

• Provide IT expertise to process equipment and automation systems for manufacturing operations.
• Enhance, develop and support MES applications including validation execution.
• Perform process analysis and validate improvements for automation systems.
• Join implementation projects for integrated business applications and automation.
• Support installation, configuration, troubleshooting and maintenance of computerized systems.
• Train users to ensure proper use of software following procedures.
• Assist Site Automation/Manufacturing in workload/capacity planning.
• Review and test programs to meet hardware/software requirements.
• Assess component loss criticality and draft recovery recommendations.
• Provide project status updates and strive to meet milestones.

Skills

GAMP 5

21 CFR Part 11

SYNCADE

RDBMS

Crystal Reports

Process automation

MES apps

Education

Bachelor's degree in CS/CE/EE/IT

Tools

FR user tools

Job description

For Validation services in the Manufacturing Operations and Business Process area

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree in Computer Science, Computer Engineering, Electrical Engineering, or Information Technology; and five (5) years of IT experience in pharmaceutical manufacturing operations, with at least three (3) years of experience in process automation and two (2) years of experience in computerized systems validation.
• Shift: 1st shift (8:30 am- 5:00 pm)
  • Available to work in the 2nd, 3rd or weekend shifts and willing to work flexible hours, changing shifts (rotational work shifts), nights and weekends as required per business needs based on business needs.
• Bilingual: English and Spanish (verbal/ written)
• Experience in
  • Computer System Validation documentation using standards like GAMP 5, 21 CFR Part 11, and related FDA/EMEA regulatory concepts.
  • SYNCADE Application.
  • Systems development and implementation of manufacturing and quality-related systems.
  • DRP / Contingency / SLA management for optimal system up-time and minimal downtime.
  • Linear and relational database (RDBMS) management, and creation of custom reports from RDBMS, preferably using Crystal Reports.

The Personality Part:

• If you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!

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

• Provide IT expertise support to process equipment and process automation systems for manufacturing operations, and to business process teams during process integration.
• Enhance, develop and support Manufacturing Execution System (MES) applications, including user requirements, specifications, protocols and validation execution for manufacturing systems applications.
• Perform process analysis and recommend improvements, including assessment, recommendation, validation and implementation of process automation systems.
• Participate proactively as a team member on implementation projects for new integrated business applications and automation processes, providing consulting advice in the use and management of technology.
• Provide support in collaboration with the automation group for installation, configuration, troubleshooting, prototyping and maintenance of computerized systems.
• Provide continuous support and training to users to ensure proper use of software applications, following established operational procedures.
• Support Site Automation and Manufacturing teams in evaluating workload and capacity of computer systems to determine feasibility for expanding, upgrading or enhancing computer operations.
• Review and test computer programs to ensure they meet manufacturer-recommended requirements for hardware and software at the personal computer and/or host computer system level.
• Determine criticality of component loss, prioritize the importance of components, and write recommendations for recovering losses using applicable backup/restore procedures.
• Provide project status updates against project plans and perform best efforts to achieve project milestones within pre-established due dates.

BEING A FITS PIECE COMES WITH PERKS:

• One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out!

WHO WE ARE:

We are a Service Provider companydifferent 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 industryclients with top-notch quality talent.We're FITS!