What are the responsibilities and job description for the Process Engineer position at The Fountain Group?
Pay : $75 / HR to $90 / HR (depending on years of experience)
Initial Contract Length : 1 year (has ability to extend and convert)
Job Description :
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.
Lead the creation and use of digital process data analytic systems.
Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.
Key Responsibilities :
Provide technical leadership in area of responsibility. Provide technical / scientific support, expertise, and guidance to manufacturing and quality.
Ensure a solid understanding of engineering principles and theories in the area of responsibility and uses them to solve a range of complex problems in creative and practical ways.
Lead technical project team or cross-functional team between groups / organizations. Provide input and coordinates support from process development teams.
Review manufacturing processes and / or development and production data.
Design and conduct necessary experiments; contributes to understanding and interpretation of results; recommend changes or additional experiments.
Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate / implement changes if required.
Provide CMC support and guidance for product life cycle management.
Qualifications :
Bachelor’s degree in Chemical or Biochemical Engineering, or related engineering. 7 years of experience
Master's degree in Chemical or Biochemical Engineering, or related engineering. 5 years of experience
Ph.D. in Chemical or Biochemical Engineering, or related engineering. 3 years of experience
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. 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.
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