Manufacturing Specialist II

FITS LLC; Gurabo (PR); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

High-impact projects

Career growth within FITS network

Job summary

FITS is seeking a Manufacturing Specialist to support a leading biotechnology manufacturer on the floor in Juncos, Puerto Rico. This hands-on role partners with operations to keep procedures current, solve process issues, and lead investigations while helping bring new products to the floor.

The role requires strong GMP knowledge, and the candidate will use TrackWise, Veeva, SAP and MES to monitor performance, document investigations, and drive continuous improvement.

Qualifications

• Doctorate or equivalent with manufacturing operations experience.
• Master's degree plus 2+ years in manufacturing operations.
• Bachelor's degree plus 4+ years in manufacturing operations.

Responsibilities

• Maintain procedures current and support floor operations.
• Lead investigations and corrective actions on process issues.
• Assist in NPI processes and review related documentation.
• Support regulatory inspections and change controls.

Skills

GMP manufacturing knowledge

Bilingual English/Spanish

Process troubleshooting

Cross-functional collaboration

Education

Doctorate

Master's degree + 2 years Manufacturing Operations experience

Bachelor's degree + 4 years Manufacturing Operations experience

Tools

TrackWise

Veeva

SAP

MES

Job description

What Makes You A Fit:

FITS is looking for a Manufacturing Specialist to support a leading biotechnology manufacturer in Juncos, Puerto Rico. 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.

• Educationrequirements:
  • 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, asneededbybusiness.

Preferred Qualifications

• 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

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.