Biotech Manufacturing Specialist II - GMP Floor Expert

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

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.