Forservices in the Technical Services / Manufacturing areas
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors degree (minimum) in scientific disciplines of Biotech Chemistry BiochemistryBiology Pharmacy or Engineering.
- Three (3) years of demonstrated hands-on working experience and proficiency with spray dryand/or solid dosage manufacturing.
- Strong understanding of regulatory requirements their application and expectations in amanufacturing environment (cGMPs and applicable global regulatory guidance).
- Proficient in data management practices across manufacturing operations.
- Proven ability to effectively communicate and influence across diverse teams.
- Demonstrated project management expertise with a track record of coordinating and executingmultifaceted projects.
- Available to support 24/7 operations and issue resolutions across multiple time zones as needed.
- Excellent technical writing capabilities and documentation in English and communication skills .
- Ability to manage multiple priorities and work independently with limited supervision
- Bilingual (English & Spanish).
The Personality Part:
- 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)
- Provide technical oversight for spray dry and solid dosage manufacturing processesleveraging a strong technical foundation and previous experience supporting these processes.
- Participate in resolution of technical issues including those related to control strategy andmanufacturing.
- Authoring of deviations and change controls.
- Build manage and maintain internal and external relationships site management development and central technical organization and cross-functional teams.
- Ensure that manufacturing processes are compliant capable in control and maintained in avalidated or qualified state.
- Understand justify and document the state of process validation with data that evaluates thecapability of the manufacturing process to meet its stated purpose.
- Maintain processes in a state of compliance with US and global regulations including cGMPsand applicable global regulatory manufacturing guidance.
- Support ongoing manufacturing at External Partners through process monitoring issueresponse and process improvements where necessary.
- Work cross-functionally within the site and other functions to deliver on technical objectives.
- Operate with the client teammindset demonstrating a collaborative approach and positiveattitude toward change.
- Comply with all site training policies and procedures.
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
Required Experience:
Senior IC
Forservices in the Technical Services / Manufacturing areasWHAT MAKES YOU A FIT:The Technical Part:Bachelors degree (minimum) in scientific disciplines of Biotech Chemistry BiochemistryBiology Pharmacy or Engineering.Three (3) years of demonstrated hands-on working experience and proficiency with sp...
Forservices in the Technical Services / Manufacturing areas
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors degree (minimum) in scientific disciplines of Biotech Chemistry BiochemistryBiology Pharmacy or Engineering.
- Three (3) years of demonstrated hands-on working experience and proficiency with spray dryand/or solid dosage manufacturing.
- Strong understanding of regulatory requirements their application and expectations in amanufacturing environment (cGMPs and applicable global regulatory guidance).
- Proficient in data management practices across manufacturing operations.
- Proven ability to effectively communicate and influence across diverse teams.
- Demonstrated project management expertise with a track record of coordinating and executingmultifaceted projects.
- Available to support 24/7 operations and issue resolutions across multiple time zones as needed.
- Excellent technical writing capabilities and documentation in English and communication skills .
- Ability to manage multiple priorities and work independently with limited supervision
- Bilingual (English & Spanish).
The Personality Part:
- 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)
- Provide technical oversight for spray dry and solid dosage manufacturing processesleveraging a strong technical foundation and previous experience supporting these processes.
- Participate in resolution of technical issues including those related to control strategy andmanufacturing.
- Authoring of deviations and change controls.
- Build manage and maintain internal and external relationships site management development and central technical organization and cross-functional teams.
- Ensure that manufacturing processes are compliant capable in control and maintained in avalidated or qualified state.
- Understand justify and document the state of process validation with data that evaluates thecapability of the manufacturing process to meet its stated purpose.
- Maintain processes in a state of compliance with US and global regulations including cGMPsand applicable global regulatory manufacturing guidance.
- Support ongoing manufacturing at External Partners through process monitoring issueresponse and process improvements where necessary.
- Work cross-functionally within the site and other functions to deliver on technical objectives.
- Operate with the client teammindset demonstrating a collaborative approach and positiveattitude toward change.
- Comply with all site training policies and procedures.
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
Required Experience:
Senior IC
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