Join the process development team that supports commercial sterile vial filling at a leading biotechnology company in Juncos, Puerto Rico. You will design the studies and set the process parameters that keep aseptic manufacturing robust. This is a hands-on development role, not a documentation role.

What you'll do

• Design and run process characterization and optimization studies for aseptic filling.
• Set and justify process parameters; troubleshoot commercial process issues.
• Analyze data in JMP or Minitab and recommend improvements.
• Author protocols, technical reports, investigations and change controls; support PPQ and tech transfer.

Requirements

• Bachelor's degree + 5 years, Master's + 3 years, or PhD/PharmD (Engineering, Pharmaceutical Sciences, Biotechnology, Biology or Microbiology).
• Experience developing processes and establishing parameters for sterile drug product (not only validation).
• Aseptic processing, contamination control and GMP.
• JMP or Minitab, LIMS; bilingual English/Spanish.

Benefits

• Contract: 6 months, with possible extension
• Shift: Administrative, Monday–Friday
• Start: Immediate