Currently I have an opening for an Process Engineer / Scientist located in Framingham, MA. Details for the position are as follows:
Technical Information:
- Pay: $80-90 hourly, depending on experience level
- Onsite, M-F, 8am-430pm (Fully ONSITE!)
- 12-month contract with potential for extension/conversion
Qualifications:
- Bachelor's 7 / Master's 5 / PhD 3 years' of experience in downtream purification in a commercial setting including AKTA, HPLC, Filtration, UF/DF, Chromatography, Viral clearance, and leachable and extractables.
Job Description:
- Manufacturing Science is a partner of biologics manufacturing operations and is the custodian of manufacturing processes. Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.
- Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement
- Anticipate, respond to, and permanently resolve issues that arise during production.
- Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.
- Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.
- 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.
- Knowledge of computerized systems in biopharmaceutical manufacturing environment, i.e., Distributed Control System, Process Data Historian, LIMS, and MES.