Manufacturing Specialist II

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.

• Manufacturing experience providing on-the-floor support, assessing process performance by observing floor operations and reviewing performance data
• Experience initiating, revising, and approving manufacturing procedures
• Process troubleshooting support
• Participation in the NPI process, assessing documentation, materials, and training requirements
• Assisting manufacturing change owners on CCRB packages impacting the process
• Participation in assessing or implementing special projects or initiatives

• 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!

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