What are the responsibilities and job description for the Manager, Quality Management and Validation Engineering - 25-71230 position at cyberThink Inc?
Job Description :
This position is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at the industrial sites. The mission is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC).
Job Responsibilities :
- Write protocols, reports, procedures, and memos as needed to support adjuvant manufacturing activities as they relate to engineering, investigational, definition, development and process validation runs.
- Support execution of development and validation related studies.
- Document and interpret study results with recommendations.
- Provide technical leadership as a subject matter expert in multiple areas of responsibility.
- Develop and execute training programs for appropriate audiences.
- Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
- Provide leadership, including project team leadership, within area of expertise.
- Assist with assessing existing processes and workflows.
- Translate processes to commercial operations.
- Ownership of equipment unit operations and technology capabilities.
- Communicates findings and proposals to upper management.
- Improve Manufacturing Technology strategic programs by supporting non-conformance issues related to change controls, deviations, corrective and preventative actions (CAPAs).
- Participate in Gemba / shop floor walk through to learn about production processes and / or interview stakeholders to collect data for continuous improvement of strategic programs and development of validation strategies / documents.
- Develop and update standard operating procedures and related technical documents to align to program strategies under a cGMP environment.
- Work closely with other members of the department to share knowledge and competencies encouraging individual growth and technical contributor.
Education & experience :
The hourly range for roles of this nature are $60.00 to $90.00 / hr. Rates are heavily dependent on skills, experience, location, and industry.
Salary : $60 - $90
