Engineer, Process Engineer

Overview

Onsite 8-5 PM Local time.

• We are seeking a skilled Process Development Engineer who can work independently to support technical projects.
• The ideal candidate will have expertise in laboratory testing, drug product fill finish processing, holistic drug product process knowledge, technical transfer, and drug product manufacturing.
• Excellent communication skills and proficiency in technical writing are essential for this role.
• Author, data verify, and review guideline documents, technical protocols, reports, product impact assessments.
• Execute laboratory analytical testing such as: viscosity, protein concentration, pH, osmolality.
• Execute laboratory experiments such as pipetting, formulation, filtration.
• Provide technical support for drug product process development, including formulation, filtration, and filling (vials/syringes/devices) of parenteral products.
• Assist in the development and characterization of drug product processes and the transfer of new technologies to commercial sterile fill/finish sites.
• Support process development for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer, and validation.
• Collaborate with manufacturing and support functions to provide coordinated support for commercial drug product manufacturing operations and technology transfer.
• Participate in global cross-functional teams, working effectively in a highly matrixed team environment to drive efficiency and foster strong relationships.
• Troubleshoot issues with drug product processing technologies and equipment, utilizing data-driven analyses and visualizations to determine true root causes.