About the role
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?