What Makes You A Fit:
FITS is looking for a Manufacturing Specialist to support a leading biotechnology manufacturer. This is a hands-on, floor-facing role. You’ll be the technical partner to manufacturing operations, keeping procedures current, solving process issues, leading investigations, and helping bring new products to the floor. If you know GMP manufacturing from the inside and enjoy being where the action is, this role is for you.
Education requirements: a Doctorate
a Master’s plus 2+ years of Manufacturing Operations experience
a Bachelor’s plus 4+ years of Manufacturing Operations experience
Bilingual (English & Spanish).
Shift: Administrative, as needed by business.
Preferred Qualifications Complete risk assessments, Change Controls, CAPAs, and manage CDOCS.
Participation in assessing or implementing special projects or initiatives
As a Piece of FITS You Will Serve as document owner, keeping manufacturing procedures aligned with current operations
Observe floor operations and review performance data to plan and implement process improvements
Troubleshoot manufacturing processes, applying a detailed technical understanding of bioprocessing unit operations
Create training materials and support training on the scientific and technical aspects of the process
Help establish process monitoring parameters and control limits, collect monitoring data, and apply control charting
Support timely completion of quarterly process monitoring reports
Triage non-conformances within established goals, author investigation reports, and execute corrective actions
Manage NC/CAPA closure on time, and monitor and communicate incident trends
Review equipment and system root cause analysis investigations and support trend evaluations
Help generate and execute process validation protocols and reports, and collect and analyze validation data
Participate in regulatory inspections
Assess, prioritize, and support implementation of process or equipment modification projects
Serve as primary process owner for process support systems, and support ownership of more complex systems
Collaborate with Manufacturing, Process Development, and Quality, and help lead cross-functional teams
Use quality and manufacturing systems such as TrackWise, Veeva, SAP, and MES platforms
Being a FITS Piece Comes With Perks
Work on high-impact projects with one of Puerto Rico’s top biotechnology manufacturers
Opportunities to grow your career across FITS’ network of clients in pharma, biotech, and medical devices
Who We Are
FITS is a Puerto Rico-based engineering and technical firm. We connect skilled professionals with leading companies in regulated industries, including pharmaceutical, biotech, medical device, and manufacturing. We believe the right talent fits like the right piece, and we work to make every placement a lasting match.
Ready to be a Piece of FITS? Apply today!