What are the responsibilities and job description for the Process Engineer - Downstream position at Systems Ally?
Process Engineer-DOWNSTREAM W2 only
BASIC 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. Performs work that consistently
requires independent decision making and the exercise of independent judgment and discretion.
• Ability to navigate ambiguous circumstance to meet final objectives.
• Strong communication and technical writing skills. Experience communicating with business
partners and senior management.
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
Bachelor’s degree in chemical or Biochemical Engineering, or related engineering disciplines
with 10 years of relevant experience in the biopharmaceutical or pharmaceutical related
- industry
