Senior Manager C&Q-1400007753W
Description
Reporting to the Operation Readiness Director of JNJ supply chain manufacturing base of Xian project, the Manager Commissioning and Qualifications will be responsible for Commissioning and Qualification (C&Q) program and ensure compliance with corporate and regulatory guidelines. Commissioning and Qualification Manager will be a key contributor to the Operation Readiness team. The Manager C&Q will work closely with key stakeholders in a variety of departments to assure all design changes, commissioning / qualification needs, and operational support requirements are met.
RESPONSIBILITIES WILL INCLUDE:
1. C&Q cost and schedule control.
2. Interface with the project teams to develop the overall C&Q phase project plan and schedule which includes risk assessment, design review/DQ, test matrix, FAT, SAT/commissioning, installation, operational and performance qualification for all systems.
3. Developing the commissioning and qualification master plans, identify task lists and project timelines in line with the objectives and goals of the projects, and propose sub-plans to facilitate the C&Q process, and eliminate road blocks.
4. Working closely with Automation/IT team to make sure readiness for facility, process and clean utilities such as MES, material handling system, environmental monitoring systems (Data Acquisition) / building management systems (HVAC controls) and process/utility control systems.
5. Managing commissioning and qualification phase improvement.
6. Ensuring C&Q program alignment with JNJ corporate standards along with engineering best practices. Provide oversight to project contractors to ensure C&Q program are followed per procedures.
7. Responsible for project C&Q documentation management and quality of the turnover documentation library.
8. Responsible for the C&Q staff plan, hiring, management, mentoring and development.
9. Management for other C&Q activities:
• Determine the C&Q tasks by categorizing project system list.
• Review & Approve C&Q documentation.
• Manage all required training on GMP, EHS, JNJ standard and protocol implementation in time.
• Regular meeting with C&Q team, regular C&Q status update to project management and stakeholders.
• Ensure JNJ EHS guidelines are met during C&Q execution. Monitor/evaluate contractor safety performance throughout the C&Q duration of the project.
• Manage and close major deficiencies (punch list and exceptions list) in time before next phase.
LEADERSHIP QUALIFICATIONS:
• This individual should be a self-starter with strong interpersonal, organizational, and technical skills. Capability to work both independently and in a team environment. Strong analytical and communications skills are required.
• Excellent written and verbal presentation skills to support interactions with management are required.
• Must be able to establish strong working relationships with stakeholders (project management, quality, operation, system owner and tech. transfer) to ensure high quality deliverables meeting cGMP and site quality requirements.
Qualifications
REQUIRED QUALIFICATION:
• Minimum University degree in Engineering.
• Minimum of five (5) years of previous engineering experience in C&Q.
• Experience in C&Q of pharmaceutical facilities and aseptic processes is an asset.
• Experience with current commissioning and qualification methods, including ISPE, ICH, and ASTM E2500 methodology such as risk management methods.
• Knowledge of China and EU regulatory requirements relevant to formulation facilities.
• Excellent problem solving and troubleshooting abilities.
• High level of familiarity with Excel, Word, Access, and Microsoft Project.
• Strong time management and project management skills.
• Ability to work in a fast paced environment.
• Excellent oral and written communication skills in English.
• Customer service orientated.
Primary Location:Asia Pacific-China-Shaanxi-Xi'an
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function: Validation
Description
Reporting to the Operation Readiness Director of JNJ supply chain manufacturing base of Xian project, the Manager Commissioning and Qualifications will be responsible for Commissioning and Qualification (C&Q) program and ensure compliance with corporate and regulatory guidelines. Commissioning and Qualification Manager will be a key contributor to the Operation Readiness team. The Manager C&Q will work closely with key stakeholders in a variety of departments to assure all design changes, commissioning / qualification needs, and operational support requirements are met.
RESPONSIBILITIES WILL INCLUDE:
1. C&Q cost and schedule control.
2. Interface with the project teams to develop the overall C&Q phase project plan and schedule which includes risk assessment, design review/DQ, test matrix, FAT, SAT/commissioning, installation, operational and performance qualification for all systems.
3. Developing the commissioning and qualification master plans, identify task lists and project timelines in line with the objectives and goals of the projects, and propose sub-plans to facilitate the C&Q process, and eliminate road blocks.
4. Working closely with Automation/IT team to make sure readiness for facility, process and clean utilities such as MES, material handling system, environmental monitoring systems (Data Acquisition) / building management systems (HVAC controls) and process/utility control systems.
5. Managing commissioning and qualification phase improvement.
6. Ensuring C&Q program alignment with JNJ corporate standards along with engineering best practices. Provide oversight to project contractors to ensure C&Q program are followed per procedures.
7. Responsible for project C&Q documentation management and quality of the turnover documentation library.
8. Responsible for the C&Q staff plan, hiring, management, mentoring and development.
9. Management for other C&Q activities:
• Determine the C&Q tasks by categorizing project system list.
• Review & Approve C&Q documentation.
• Manage all required training on GMP, EHS, JNJ standard and protocol implementation in time.
• Regular meeting with C&Q team, regular C&Q status update to project management and stakeholders.
• Ensure JNJ EHS guidelines are met during C&Q execution. Monitor/evaluate contractor safety performance throughout the C&Q duration of the project.
• Manage and close major deficiencies (punch list and exceptions list) in time before next phase.
LEADERSHIP QUALIFICATIONS:
• This individual should be a self-starter with strong interpersonal, organizational, and technical skills. Capability to work both independently and in a team environment. Strong analytical and communications skills are required.
• Excellent written and verbal presentation skills to support interactions with management are required.
• Must be able to establish strong working relationships with stakeholders (project management, quality, operation, system owner and tech. transfer) to ensure high quality deliverables meeting cGMP and site quality requirements.
Qualifications
REQUIRED QUALIFICATION:
• Minimum University degree in Engineering.
• Minimum of five (5) years of previous engineering experience in C&Q.
• Experience in C&Q of pharmaceutical facilities and aseptic processes is an asset.
• Experience with current commissioning and qualification methods, including ISPE, ICH, and ASTM E2500 methodology such as risk management methods.
• Knowledge of China and EU regulatory requirements relevant to formulation facilities.
• Excellent problem solving and troubleshooting abilities.
• High level of familiarity with Excel, Word, Access, and Microsoft Project.
• Strong time management and project management skills.
• Ability to work in a fast paced environment.
• Excellent oral and written communication skills in English.
• Customer service orientated.
Primary Location:Asia Pacific-China-Shaanxi-Xi'an
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function: Validation