For services in the Technical Services / Manufacturing areas
WHAT MAKES YOU A FIT:
The Technical Part:
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Bachelor's degree (minimum) in scientific disciplines of Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering.
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Three (3+) years of demonstrated hands-on working experience and proficiency with spray dry and/or solid dosage manufacturing.
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Strong understanding of regulatory requirements, their application, and expectations in a manufacturing environment (cGMPs and applicable global regulatory guidance).
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Proficient in data management practices across manufacturing operations.
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Proven ability to effectively communicate and influence across diverse teams.
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Demonstrated project management expertise with a track record of coordinating and executing multifaceted projects.
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Available to support 24/7 operations and issue resolutions across multiple time zones as needed.
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Excellent technical writing capabilities and documentation in English, and communication skills .
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Ability to manage multiple priorities and work independently with limited supervision
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Bilingual (English & Spanish).
The Personality Part:
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If you consider yourself an ingenious and creative problem-solver with an uncanny ability to lead, then this is the job for you! Sprinkle on a love for the scientific method, teamwork, and, above all else, being ethical and you just might have what it takes to take on this new challenge. Bring it on!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
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Provide technical oversight for spray dry and solid dosage manufacturing processes, leveraging a strong technical foundation and previous experience supporting these processes.
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Participate in resolution of technical issues, including those related to control strategy and manufacturing.
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Authoring of deviations and change controls.
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Build, manage, and maintain internal and external relationships, site management, development and central technical organization, and cross-functional teams.
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Ensure that manufacturing processes are compliant, capable, in control, and maintained in a validated or qualified state.
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Understand, justify, and document the state of process validation with data that evaluates the capability of the manufacturing process to meet its stated purpose.
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Maintain processes in a state of compliance with US and global regulations, including cGMPs and applicable global regulatory manufacturing guidance.
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Support ongoing manufacturing at External Partners through process monitoring, issue response, and process improvements where necessary.
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Work cross-functionally within the site and other functions to deliver on technical objectives.
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Operate with the client team mindset, demonstrating a collaborative approach and positive attitude toward change.
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Comply with all site training, policies and procedures.
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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