Engineering Director-00000KF7
Description
- Leading or supporting new product introduction and in-line technology transfer commercialization projects
- Providing pharmaceutical process engineering expertise and developing technology transfer, equipment qualification, process and cleaning validation strategies to facility expansion and upgrade initiatives
- Developing and executing process, packaging, and cleaning validation strategies and site validation master plans and ensuring continuous compliance with regulatory and internal JSC policies and standards
- Applying proactive process analysis in risk assessment and product life cycle management
- Identifying and leading process improvement and value capture opportunities by utilizing lean six sigma tools and methodologies
- Providing process and equipment trouble-shooting and root-cause analysis expertise, supporting the change management process
- Acting as a liaison between the manufacturing plant personnel and global technology platforms and other global functions to engage and solicit the support of relevant subject matter experts and leverage the technical knowledge across the global technical community
- Promoting behaviors and principles that drive a continuous improvement and a strong compliance culture
· Constantly developing the GTS regional team’s pharmaceutical engineering and validation knowledge and capability to enhance the team’s overall effectiveness and ensure that it has the required skills to handle all sites’ technical requirements
Qualifications
Education: Bachelor, Master or PhD Degree in scientific or applied field, preferably in Chemical Engineering, Chemistry or Pharmacy
Experience: Minimum 10 years relevant work experience in the pharmaceutical industry. One or more leadership roles in technical operations, quality operations, engineering, or supply chain management. Background in process development, safety and environmental, manufacturing and process design, and project management is desired.
Key required competencies
- Broad skills and experience in pharmaceutical process technology and project management
- Demonstrated leadership skills with a strong capability to coach, motivate, lead and manage people, teams, process, and projects
- Knowledge of applicable cGMP’s and regulatory requirements, especially: process, cleaning, and equipment validation, change control, and good manufacturing practices
- Strong analytical and problem solving skills
- Demonstrated organizational skills, proactive, creative and self-motivated with ability to multi-task
- Strong communication skills, negotiation skills, resourceful, committed, and effectively works cross-functionally at all levels of the organization
- Demonstrated capability to analyze data, highlight trends and exceptions, and provide useful insights
- Demonstrated capability in application of appropriate trouble-shooting and problem solving techniques
- Demonstrated knowledge and application of Lean Six Sigma methodology
· Maintains high ethical standards and strict confidentiality of all sensitive information
Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Travel:Yes, 25 % of the Time
Job Function: Engineering
Description
- Leading or supporting new product introduction and in-line technology transfer commercialization projects
- Providing pharmaceutical process engineering expertise and developing technology transfer, equipment qualification, process and cleaning validation strategies to facility expansion and upgrade initiatives
- Developing and executing process, packaging, and cleaning validation strategies and site validation master plans and ensuring continuous compliance with regulatory and internal JSC policies and standards
- Applying proactive process analysis in risk assessment and product life cycle management
- Identifying and leading process improvement and value capture opportunities by utilizing lean six sigma tools and methodologies
- Providing process and equipment trouble-shooting and root-cause analysis expertise, supporting the change management process
- Acting as a liaison between the manufacturing plant personnel and global technology platforms and other global functions to engage and solicit the support of relevant subject matter experts and leverage the technical knowledge across the global technical community
- Promoting behaviors and principles that drive a continuous improvement and a strong compliance culture
· Constantly developing the GTS regional team’s pharmaceutical engineering and validation knowledge and capability to enhance the team’s overall effectiveness and ensure that it has the required skills to handle all sites’ technical requirements
Qualifications
Education: Bachelor, Master or PhD Degree in scientific or applied field, preferably in Chemical Engineering, Chemistry or Pharmacy
Experience: Minimum 10 years relevant work experience in the pharmaceutical industry. One or more leadership roles in technical operations, quality operations, engineering, or supply chain management. Background in process development, safety and environmental, manufacturing and process design, and project management is desired.
Key required competencies
- Broad skills and experience in pharmaceutical process technology and project management
- Demonstrated leadership skills with a strong capability to coach, motivate, lead and manage people, teams, process, and projects
- Knowledge of applicable cGMP’s and regulatory requirements, especially: process, cleaning, and equipment validation, change control, and good manufacturing practices
- Strong analytical and problem solving skills
- Demonstrated organizational skills, proactive, creative and self-motivated with ability to multi-task
- Strong communication skills, negotiation skills, resourceful, committed, and effectively works cross-functionally at all levels of the organization
- Demonstrated capability to analyze data, highlight trends and exceptions, and provide useful insights
- Demonstrated capability in application of appropriate trouble-shooting and problem solving techniques
- Demonstrated knowledge and application of Lean Six Sigma methodology
· Maintains high ethical standards and strict confidentiality of all sensitive information
Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Travel:Yes, 25 % of the Time
Job Function: Engineering