Website CYNET SYSTEMS
CYNET SYSTEMS
Company : CYNET SYSTEMS
Job Description:
Pay Range: $85.03hr – $90.03hr
Responsibilities:
Provide technical leadership in the 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 coordinate 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.
Attend training and scientific meetings to remain current with technology and regulatory guidelines.
May differ among employees with the same job title and may change over time in accordance with business needs.
Basic Qualifications:
Bachelor s Degree in Chemical or Biochemical Engineering, or related engineering disciplines.
7 years of relevant experience in the biopharmaceutical or pharmaceutical related industry.
Master s Degree in Chemical or Biochemical Engineering, or related engineering disciplines.
5 years of relevant experience in the biopharmaceutical or pharmaceutical related industry.
Doctor s Degree in Chemical or Biochemical Engineering, or related engineering disciplines.
3 years of relevant experience in the biopharmaceutical or pharmaceutical related industry
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 circumstances to meet final objectives.
Strong communication and technical writing skills.
Experience communicating with business partners and senior management.
Special Working Conditions:
Ability to gown and gain entry to manufacturing areas.