Technical skills
Technical writing
About this role
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