Global Technical Services Director-00000Q59
Description
·Constantly developing staff’s technical & leadership knowledge and capabilities to enhance the team’s overall effectiveness and to achieve and maintain highest performance standards
·Leading or supporting new product introduction and in-line technology transfer commercialization projects
·Providing pharmaceutical process engineering and validation expertise to plant expansion and upgrade projects
- Developing and executing process, packaging, and cleaning validation strategies and site validation master plans and ensuring continuous compliance
- Conducting proactive process analysis in risk assessment and product life cycle management
- Identifying and supporting 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 change management process, and equipment/facility upgrades and qualification initiatives
- Supporting preparation and review of product annual reports
- 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 staff’s technical & leadership knowledge and capabilities to enhance the team’s overall effectiveness and to achieve and maintain highest performance standards
- Leading or supporting new product introduction and in-line technology transfer commercialization projects
- Providing pharmaceutical process engineering and validation expertise to plant expansion and upgrade projects
- Developing and executing process, packaging, and cleaning validation strategies and site validation master plans and ensuring continuous compliance
- Conducting proactive process analysis in risk assessment and product life cycle management
- Identifying and supporting 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 change management process, and equipment/facility upgrades and qualification initiatives
- Supporting preparation and review of product annual reports
- 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 staff’s technical & leadership knowledge and capabilities to enhance the team’s overall effectiveness and to achieve and maintain highest performance standards
- Leading or supporting new product introduction and in-line technology transfer commercialization projects
- Providing pharmaceutical process engineering and validation expertise to plant expansion and upgrade projects
- Developing and executing process, packaging, and cleaning validation strategies and site validation master plans and ensuring continuous compliance
- Conducting proactive process analysis in risk assessment and product life cycle management
- Identifying and supporting 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 change management process, and equipment/facility upgrades and qualification initiatives
- Supporting preparation and review of product annual reports
- 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
Qualifications
Education: B.Sc., M.S. or Ph.D. Degree in scientific or applied field, preferably in Chemical Engineering, Chemistry or Pharmacy
Experience: Minimum 15 years of relevant work experience in the pharmaceutical or chemical manufacturing industries. One or more leadership roles in manufacturing, 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
- Demonstrated leadership skills with a strong capability to coach, motivate, lead and manage people, teams, process, and projects
- Broad skills and experience in pharmaceutical process technology and project management
- Knowledge of applicable cGMP’s and regulatory requirements, especially: process, cleaning, and equipment validation, change control, and manufacturing practices
- Excellent technical writing skills
- Strong analytical and problem solving skills
- Demonstrated organizational skills, proactive, creative and self-motivated with ability to multi-task
- Strong communication skills, negotiation skills, objective, resourceful, proactive, committed, and effectively works cross-functionally at all levels of the organization
- Demonstrated capability in statistical data analysis, highlight trends and exceptions, and provide useful technical insights
- Demonstrated capability in application of appropriate trouble-shooting and problem solving techniques
- Demonstrated knowledge and application of Lean Six Sigma methodology
- Basic knowledge and experience in automated manufacturing execution systems
Maintains high ethical standards and strict confidentiality of all sensitive information
Primary Location:Asia Pacific-China-Shaanxi-Xi'an
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Travel:Yes, 25 % of the Time
Job Function: Quality Systems
Description
·Constantly developing staff’s technical & leadership knowledge and capabilities to enhance the team’s overall effectiveness and to achieve and maintain highest performance standards
·Leading or supporting new product introduction and in-line technology transfer commercialization projects
·Providing pharmaceutical process engineering and validation expertise to plant expansion and upgrade projects
- Developing and executing process, packaging, and cleaning validation strategies and site validation master plans and ensuring continuous compliance
- Conducting proactive process analysis in risk assessment and product life cycle management
- Identifying and supporting 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 change management process, and equipment/facility upgrades and qualification initiatives
- Supporting preparation and review of product annual reports
- 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 staff’s technical & leadership knowledge and capabilities to enhance the team’s overall effectiveness and to achieve and maintain highest performance standards
- Leading or supporting new product introduction and in-line technology transfer commercialization projects
- Providing pharmaceutical process engineering and validation expertise to plant expansion and upgrade projects
- Developing and executing process, packaging, and cleaning validation strategies and site validation master plans and ensuring continuous compliance
- Conducting proactive process analysis in risk assessment and product life cycle management
- Identifying and supporting 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 change management process, and equipment/facility upgrades and qualification initiatives
- Supporting preparation and review of product annual reports
- 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 staff’s technical & leadership knowledge and capabilities to enhance the team’s overall effectiveness and to achieve and maintain highest performance standards
- Leading or supporting new product introduction and in-line technology transfer commercialization projects
- Providing pharmaceutical process engineering and validation expertise to plant expansion and upgrade projects
- Developing and executing process, packaging, and cleaning validation strategies and site validation master plans and ensuring continuous compliance
- Conducting proactive process analysis in risk assessment and product life cycle management
- Identifying and supporting 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 change management process, and equipment/facility upgrades and qualification initiatives
- Supporting preparation and review of product annual reports
- 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
Qualifications
Education: B.Sc., M.S. or Ph.D. Degree in scientific or applied field, preferably in Chemical Engineering, Chemistry or Pharmacy
Experience: Minimum 15 years of relevant work experience in the pharmaceutical or chemical manufacturing industries. One or more leadership roles in manufacturing, 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
- Demonstrated leadership skills with a strong capability to coach, motivate, lead and manage people, teams, process, and projects
- Broad skills and experience in pharmaceutical process technology and project management
- Knowledge of applicable cGMP’s and regulatory requirements, especially: process, cleaning, and equipment validation, change control, and manufacturing practices
- Excellent technical writing skills
- Strong analytical and problem solving skills
- Demonstrated organizational skills, proactive, creative and self-motivated with ability to multi-task
- Strong communication skills, negotiation skills, objective, resourceful, proactive, committed, and effectively works cross-functionally at all levels of the organization
- Demonstrated capability in statistical data analysis, highlight trends and exceptions, and provide useful technical insights
- Demonstrated capability in application of appropriate trouble-shooting and problem solving techniques
- Demonstrated knowledge and application of Lean Six Sigma methodology
- Basic knowledge and experience in automated manufacturing execution systems
Maintains high ethical standards and strict confidentiality of all sensitive information
Primary Location:Asia Pacific-China-Shaanxi-Xi'an
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Travel:Yes, 25 % of the Time
Job Function: Quality Systems