For Validation services in the Manufacturing Operations and Business Process area
WHAT MAKES YOU A FIT:
The Technical Part:
- BS in Computer Science, Computer Engineering, Electrical Engineering, or Information Technology and 5+ years of IT experience in pharmaceutical manufacturing operations.
- Bilingual: English and Spanish (verbal/ written)
- Shift: Administrative and according to business needs.
- 8:00 AM - 5:00 PM
- Experience in:
- Ticketing/ITSM Tools
- User account administration - enablement/disablement, password resets and changes.
- Infinity Knowledge- intermediate level (approve documents, upload documents, CAPA, etc)
- GMP environment
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 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?
Skills Required
- Bachelor's degree in Computer Science, Computer Engineering, Electrical Engineering, or Information Technology
- Five (5) years of IT experience in pharmaceutical manufacturing operations
- At least three (3) years of experience in process automation
- At least two (2) years of experience in computerized systems validation
- Bilingual English and Spanish (verbal and written)
- Experience with computer system validation documentation and regulatory concepts (GAMP 5, 21 CFR Part 11, FDA/EMEA)
- Experience with SYNCADE application
- Experience in systems development and implementation for manufacturing and quality-related systems
- DRP / contingency planning and SLA management for system uptime
- Linear and relational database (RDBMS) management and creation of custom reports
- Experience creating reports preferably using Crystal Reports
What We Do
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 We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]
