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.