IT Systems Specialist

For Validation services in the Manufacturing Operations and Business Process area

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelors 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 were 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 youll be amazed). However thats 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 companys 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.Were FITS!

Are you the Next Piece