For  services in Technical Services / Manufacturing supporting Dry External Manufacturing 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor's degree (minimum) in scientific disciplines of Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering.
•  Three (5+) years of demonstrated hands-on working experience and proficiency with spray dry and/or solid dosage manufacturing.
• Bilingual (English & Spanish).
•  Strong understanding of regulatory requirements, their application, and expectations in a manufacturing 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 executing multifaceted 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

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, solid dosage manufacturing and packaging processes, leveraging a strong technical foundation and previous experience supporting these processes.
  • Participate in resolution of technical issues, including those related to control strategy and manufacturing.
  • Possess excellent technical writing capabilities, including authoring of deviations and change controls.
• Participate in root cause investigations to support Corrective Actions and Preventive Actions (CAPA) closure Activities within the expected timeline. 
  • Employ excellent communication skills to manage internal and external relationships with external partners, site management, and cross-functional teams.
  • Build and maintain relationships with development and central technical organizations.
  • Ensure that manufacturing processes are compliant, capable, in control, and maintained in a validated or qualified state.
  • Understand, justify, and document the state of process validation with data that evaluates the capability of the manufacturing process to meet its stated purpose.
  • Maintain processes in a state of compliance with US and global regulations, including cGMPs and applicable global regulatory manufacturing guidance.
  • Support ongoing manufacturing at External Partners through process monitoring, issue response, and process improvements where necessary.
  • Support technical transfer and validation activities to external partners manufacturing and packaging sites by review technical transfer documentation, participate in process qualifications activities and support validation campaigns.
  • Work cross-functionally within the site and other functions to deliver on technical objectives.
   

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?