Manufacturing Scientist

FITS LLC; Carolina, Northern (PR, KY); On-site; USD 90,000 - 120,000; Full time

Job summary

FITS LLC is seeking a technically skilled professional to support spray drying and solid dosage manufacturing across a 24/7 operation. The role emphasizes regulatory compliance, data integrity, and strong writing skills to document deviations and change controls.

You will lead cross‑functional teams, coordinate with external partners, and drive process improvements while ensuring manufacturing remains in control and validated.

Qualifications

• Bachelor's degree in biotech, chemistry, biochemistry, biology, pharmacy, or engineering.
• 5+ years hands-on spray dry/s solid dosage manufacturing experience.
• Bilingual English and Spanish.
• Knowledge of cGMPs and global regulatory guidance.
• Proficient in data management across manufacturing operations.
• Strong communication and cross-functional collaboration.
• Project management experience with coordinating multifaceted projects.
• Available to support 24/7 operations across time zones.
• Excellent English technical writing and documentation.
• Ability to manage multiple priorities with limited supervision.

Responsibilities

• Provide technical oversight for spray dry and solid dosage processes.
• Participate in resolution of technical issues related to control strategy and manufacturing.
• Author deviations and change controls with strong technical writing.
• Lead root cause investigations for CAPA closure within timelines.
• Manage internal and external relationships with partners and cross-functional teams.
• Ensure processes are compliant, in control, and validated.
• Justify and document process validation with data demonstrating capability.
• Support external partner manufacturing and packaging sites.
• Collaborate cross-functionally to achieve technical objectives.

Skills

Regulatory knowledge

Data management

Communication

Project management

Bilingual (EN/ES)

Cross-functional influence

Technical writing

Time-zone adaptability

Independent work

Education

Bachelor's degree in biotech/chemistry/biochemistry/biology/pharmacy/engineering

Job description

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 dryand/or solid dosage manufacturing.
• Bilingual (English & Spanish).
• 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

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 packagingprocesses, leveraging a strong technical foundation and previous experience supportingthese processes.
  • Participate in resolution of technical issues, including those related to control strategy andmanufacturing.
  • Possess excellent technical writing capabilities, including authoring of deviations andchange 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 maintainedin a validated or qualified state.
  • Understand, justify, and document the state of process validation with data that evaluatesthe capability of the manufacturing process to meet its stated purpose.
  • Maintain processes in a state of compliance with US and global regulations, includingcGMPs and applicable global regulatory manufacturing guidance.
  • Support ongoing manufacturing at External Partners through process monitoring, issueresponse, and process improvements where necessary.
  • Support technical transfer and validation activities to external partners manufacturing andpackaging sites by review technical transfer documentation, participate in processqualifications activities and support validation campaigns.
  • Work cross-functionally within the site and other functions to deliver on technicalobjectives.

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 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 industryclients with top-notch quality talent. We're FITS!

Are you the next piece?