Provides support to the automation and computerized systems in Manufacturing and Utilities Areas.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor's Degree in Science with (5) years of experience in electrical, computer, mechanical engineering, and related fields.
- Communication Skills
- Shift: Administrative and according to business needs.
- Experience in:
- Process Automation, CSV investigations, and deviations.
- Troubleshooting (SCADA/PLC).
- FDA regulatory compliance (internal and external).
- Project Management for validations and qualifications.
The Personality Part:
- Being self-motivated means that you are curious and anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail that nothing gets past you. If this sounds like you, and 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)
- Proficient knowledge of computer system life cycle concepts, change control systems, and FDA regulatory requirements, including 21 CFR Part 11.
- Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications.
- In-depth knowledge of the science and physics involved in designing, installing, commissioning, and validation/qualification of computerized systems and PLCs as applied to pharmaceutical production environments.
- Broad knowledge of relevant governmental regulations, cGMPs, and guidelines about a biopharmaceutical manufacturing plant.
- Experience with external and internal regulatory audits (FDA, EMA, Otsuka, Sanofi, etc.
- Knowledge of pharmaceutical business processes and equipment.
- Knowledge of mechanical concepts, electrical controls theory, and electronic circuitry.
- Proven skills in project management, systems development, and implementation of manufacturing, MES Systems, and quality-related systems.
- Ability to manage and operate computer software packages used for data acquisition systems and PLC programming, including (not limited to) Rockwell Automation platform visualization and programming solutions/tools.
- Knowledge of data historian (including, but not limited to, OSI PI-FactoryTalk Historian), Databases (MS SQL), and networking infrastructure and topologies.
WHO WE ARE:
We are a service provider company that is 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 the well-being of our resources while providing our pharmaceutical, medical device, and manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?
Top Skills
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]
