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Provides support to the automation and computerized systems Manufacturing and Utilities Areas . WHAT MAKES YOU A FIT: The Technical Part: Bachelor Degree of Science in electrical, computer, mechanical engineering and or related fields . (5) five years of experience in Pharmaceutical or manufacturing processes.
Four (4) years of experience in Project Manager or Process Automation.
Two (2) years of experience in CSV. Experience in: Internal and External in FDA regulatory compliance. Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customers at all organizational levels and disciplines in such a way to facilitate the validation/qualification work.
Able to plan and prioritize multiple complex activities simultaneously (i.e., installation, integration, commissioning and validations/qualifications, timelines, etc.)
by using sound Project Management Skills.
Self-starter and well organized.
Ability to keep work pace and/or meet deadlines.
Ability to exercise good judgment.
The Personality Part: Being self-motivated means that you are curious, 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 the design, installation, commissioning and validation/qualification of computerized systems and PLCs as applied to pharmaceutical production environment.
Broad knowledge of relevant governmental regulations, cGMPs and guidelines pertaining to 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 projects 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 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?
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