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Director, Commissioning & Qualification-00000NKL
Description
Johnson & Johnson is recruiting for a Commissioning & Qualifications Director to be located at any J&J site throughout the world.
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $65 billion in 2011 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.
This position provides global leadership for: the Development, the Deployment and the Maintenance of the Detailed Process, the Standard, the Guidance and the Templates to support Commissioning & Qualification (C&Q) and Specification, Design & Verification (SD&V) efforts within J&J cross-sector; supporting J&J capital projects globally with respect to Commissioning and Qualifications, in alignment with Projects.
Responsibilities include to establish and coordinate the C&Q SME (Subject Matter Experts) Community, to evolve it into a Center of Excellence. To promote SME’s development and skill enhancement. To Integrate C&Q/SD&V process in Project Delivery Methodologies. To identify and partner with external pre-qualified companies/consultant(s). To Develop, maintain, train and drive the adoption of C&Q/SD&V on capital projects. To provide input to the overall Project Execution Plan for the projects in order to ensure C&Q is correctly defined in alignment with World Wide Engineering and Technical Operations practices for C&Q. To review affiliate qualification practices/procedures with respect to the project set up and intended C&Q approach. To support local affiliate in any adjustments which may be required with the aim of creating a robust, efficient commissioning and qualification strategy to suit the project.
Additional responsibilities include;
To Support the setup of a Commissioning/SD&V strategy and resource manning. To set up and chair strategic and tactical C&Q workshops at appropriate times in the project to ensure alignment and identify gaps. To close gaps with project team as appropriate. To follow up on workshops with stage gate reviews to ensure strategy is being implemented correctly and support issues as necessary.
To support the setup of a commissioning strategy, including the following aspects ; Train Green tag/Blue tag commissioning approach to the team. To train and advise on use of test matrices, including support on developing same – used to schedule and plan the commissioning activities for the project. To review and advise on commissioning plan. To review and advice on proposed commissioning schedule (including document preparation schedule). To review/set up start up sequence (dependencies of systems). To review and advice on the development of test documentation
To support and advice on set up of project change management program. To review of commissioning team set up and verify resource loading vs schedule. To ensure automation/process control strategy is aligned with overall C&Q strategy.
In case the project requires Qualification activities: To define the Qualification strategy for the project in coordination with the client site. To align the commissioning strategy with the Qualification strategy, in order to facilitate maximal leveraging of commissioning data to support qualification activities.
Depending on roles and responsibilities between World Wide Engineering and Technical Operations, and the client site; to be responsible for oversight of qualification activities in line with the Qualification strategy (typically up to OQ activities). To develop/support strategy of project handover to the client sites (including training, align C&Q activities with operational readiness eg. Document handover, facility operation, maintenance and housekeeping strategy)
J&J have guidance documents, tools, templates, training material available based on the ASTM 2500 approach to C&Q. The candidate will be expected to familiarize themselves with these documents/philosophy (known as SD&V – Specification, Design & Verification), in order to support sites which anticipate using this particular C&Q approach. He will facilitate Session to Capture lessons learned from projects to optimize and maintain the WWE&TO toolset with regards to commissioning and qualification
Qualifications
A minimum of a Bachelor’s Degree with a minimum of 10 years Related Business Experience is required. Multi region experience is preferred. An Advanced degree is preferred for this role.
Knowledge, Skills and Abilities include the ability to interface with Technical Leaders across Sectors and Functions (Engineering, Quality, Operations, Procurement), as well as with External Project Partners (Construction Management Firms, Vendors, Qualification Service Providers) is requirement. J&J leadership experience is preferred.
Proven Knowledge of C&Q methodologies is asset. Proven Experience in C&Q Leadership on Projects Development and Execution is required for this role.
Advanced Training skills are an asset. Knowledge in the development of processes is required. Proven experience in establishing external relationships and benchmarking is required.
Demonstrated cross enterprise influence and deployment experience is an asset for this role.
Having a global and enterprise-wide mindset is an asset. Forges internal collaboration across levels of the enterprise is an asset. Translate insights into innovative and viable solutions that create value is an asset
Written and verbal communication skills at an acceptable level in English is a required
Mature understanding of GxP’s and Regulations, EHS- Environmental Health and Safety, HCC- Health Care Compliance, ASTM and Sites Operations and Supply Chain Management are requirements for this position.
This position will require the ability to travel up to 40% both domestic and international.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
Primary Location:North America-United States-New Jersey-New Brunswick
Other Locations:North America, Europe/Middle East/Africa, Latin America, Asia Pacific
Organization: Johnson & Johnson International (6078)
Job Function: Engineering (Generalist)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Director, Commissioning & Qualification-00000NKL
Description
Johnson & Johnson is recruiting for a Commissioning & Qualifications Director to be located at any J&J site throughout the world.
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $65 billion in 2011 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.
This position provides global leadership for: the Development, the Deployment and the Maintenance of the Detailed Process, the Standard, the Guidance and the Templates to support Commissioning & Qualification (C&Q) and Specification, Design & Verification (SD&V) efforts within J&J cross-sector; supporting J&J capital projects globally with respect to Commissioning and Qualifications, in alignment with Projects.
Responsibilities include to establish and coordinate the C&Q SME (Subject Matter Experts) Community, to evolve it into a Center of Excellence. To promote SME’s development and skill enhancement. To Integrate C&Q/SD&V process in Project Delivery Methodologies. To identify and partner with external pre-qualified companies/consultant(s). To Develop, maintain, train and drive the adoption of C&Q/SD&V on capital projects. To provide input to the overall Project Execution Plan for the projects in order to ensure C&Q is correctly defined in alignment with World Wide Engineering and Technical Operations practices for C&Q. To review affiliate qualification practices/procedures with respect to the project set up and intended C&Q approach. To support local affiliate in any adjustments which may be required with the aim of creating a robust, efficient commissioning and qualification strategy to suit the project.
Additional responsibilities include;
To Support the setup of a Commissioning/SD&V strategy and resource manning. To set up and chair strategic and tactical C&Q workshops at appropriate times in the project to ensure alignment and identify gaps. To close gaps with project team as appropriate. To follow up on workshops with stage gate reviews to ensure strategy is being implemented correctly and support issues as necessary.
To support the setup of a commissioning strategy, including the following aspects ; Train Green tag/Blue tag commissioning approach to the team. To train and advise on use of test matrices, including support on developing same – used to schedule and plan the commissioning activities for the project. To review and advise on commissioning plan. To review and advice on proposed commissioning schedule (including document preparation schedule). To review/set up start up sequence (dependencies of systems). To review and advice on the development of test documentation
To support and advice on set up of project change management program. To review of commissioning team set up and verify resource loading vs schedule. To ensure automation/process control strategy is aligned with overall C&Q strategy.
In case the project requires Qualification activities: To define the Qualification strategy for the project in coordination with the client site. To align the commissioning strategy with the Qualification strategy, in order to facilitate maximal leveraging of commissioning data to support qualification activities.
Depending on roles and responsibilities between World Wide Engineering and Technical Operations, and the client site; to be responsible for oversight of qualification activities in line with the Qualification strategy (typically up to OQ activities). To develop/support strategy of project handover to the client sites (including training, align C&Q activities with operational readiness eg. Document handover, facility operation, maintenance and housekeeping strategy)
J&J have guidance documents, tools, templates, training material available based on the ASTM 2500 approach to C&Q. The candidate will be expected to familiarize themselves with these documents/philosophy (known as SD&V – Specification, Design & Verification), in order to support sites which anticipate using this particular C&Q approach. He will facilitate Session to Capture lessons learned from projects to optimize and maintain the WWE&TO toolset with regards to commissioning and qualification
Qualifications
A minimum of a Bachelor’s Degree with a minimum of 10 years Related Business Experience is required. Multi region experience is preferred. An Advanced degree is preferred for this role.
Knowledge, Skills and Abilities include the ability to interface with Technical Leaders across Sectors and Functions (Engineering, Quality, Operations, Procurement), as well as with External Project Partners (Construction Management Firms, Vendors, Qualification Service Providers) is requirement. J&J leadership experience is preferred.
Proven Knowledge of C&Q methodologies is asset. Proven Experience in C&Q Leadership on Projects Development and Execution is required for this role.
Advanced Training skills are an asset. Knowledge in the development of processes is required. Proven experience in establishing external relationships and benchmarking is required.
Demonstrated cross enterprise influence and deployment experience is an asset for this role.
Having a global and enterprise-wide mindset is an asset. Forges internal collaboration across levels of the enterprise is an asset. Translate insights into innovative and viable solutions that create value is an asset
Written and verbal communication skills at an acceptable level in English is a required
Mature understanding of GxP’s and Regulations, EHS- Environmental Health and Safety, HCC- Health Care Compliance, ASTM and Sites Operations and Supply Chain Management are requirements for this position.
This position will require the ability to travel up to 40% both domestic and international.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
Primary Location:North America-United States-New Jersey-New Brunswick
Other Locations:North America, Europe/Middle East/Africa, Latin America, Asia Pacific
Organization: Johnson & Johnson International (6078)
Job Function: Engineering (Generalist)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.