Process Engineer (Downstream Manufacturing)

Framingham, MA

12 MOnths ( Possible Ext)

Must have:

Previous pharma or biotech experience

Bachelor’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 7 years of relevant experience in the biopharmaceutical or pharmaceutical related industry OR Master’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 5 years of relevant experience in the biopharmaceutical or pharmaceutical related industry OR Doctor’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 3 years of relevant experience in the biopharmaceutical or pharmaceutical related industry

Strong communication skills, position will interface with multiple departments.

This team is providing technical expertise to Quality, Manufacturing, etc. all departments.

Strong understanding of GMP environments, deviations, CAPA’s

PREFERRED QUALIFICATIONS

Demonstrated expertise applying fundamental principles to real world problem solving and providing practical solutions to difficult technical issues.

Experience with biologics downstream unit operations, Filtration, UF/DF, Chromatography, Viral clearance, and leachable and extractables.

Understand cGMP concept and familiar with quality and regulatory framework.

Proficient in process data analytics

Knowledge of computerized systems in biopharmaceutical manufacturing environment, i.e., Distributed Control System, Process Data Historian, LIMS, and MES.

Experience leading projects and/or cross functional teams.

Works independently with minimal supervision and direction.

Strong communication and technical writing skills