Janssen Supply Chain (JSC) is recruiting for Fuji Site an Execution System Manager. This position must be based at Fuji Site
The rolewill be focused on implementing a standard recipe based product management processes across all the sectors in Johnson & Johnson. This will deliver the following:
1. Consistent content management
2. Optimized execution end to end
3. Proactive visualization of a preferred future for execution
The Execution Systems Manager will report dotted line to the Site General Manager and solid line to the MAM APAC Lead. The Manager will lead a team of site engineers across manufacturing and lab space for the site. This position will directly contribute to the development of business and/or functional strategies and capabilities, on site and platform levels, and serve as a liaison and single point of contact for peers within ES as well as across function within the site.
The Execution Systems Manager is responsible for ensuring that the ISA-95 level 1, 2 and 3 systems and associated operation is in compliance and fit for intended use in accordance with applicable standards and procedures throughout systems lifecycle.
The Execution Systems Manager is responsible for day-to-day operations management of ISA-95 level 1, 2 and 3 systems and ensuring system availability as per business requirements, as well as owning the site road-map execution, including oversight of campus or regional set-up (if applicable).
The focus of this position will be on maintaining content and recipe libraries, identifying business needs to support ES, establishing ES-scope ISA-95 level 2 and 3 system roadmaps and delivery for the site. Under the ES Platform lead’s leadership the Manager will be responsible for the execution of standards and delivery of business results on site.
· Provides site leadership, including obtaining agreement on site ES project definitions and priorities, and ensuring that resources, capabilities and processes are in place.
· Ensures ES programs stay on plan by resolving resource conflicts and removing obstacles, which may involve negotiations at a senior level.
· Establishes effective working relationships and develops new partnerships with PDMS, Quality, IT, Lab Systems and others to optimize methodology.
· Ensures sound technical engineering concepts are applied.
· Develops a mechanism to proactively assess business needs and identify points of leverage across the Platform.
· Responsible for leading Execution Systems engineers and Recipe Management Specialists at the site.
· Implements the content and execution standards in the end to end development and deployment of manufacturing and lab systems at the site.
· Represent Execution Systems in the Site Leadership Team.
· Ensures governance for site specific portfolio/ program and project management and execution
· Define, monitor and reports metrics and KPI
The Execution Systems Senior Manager / Manager is responsible for:
· Provides support for investigations (Events / CAPA's) and regulatory inspections
· Site compliance and adherence with global/ platform standards
· Maintains change control process aligned to global and platform processes.
· Manages ES related vendor contracts.
· Monitors system performance and conduct database administration.
· Provides feedback to Technical Operations on changes required in Master Recipe to be incorporated into Equipment Class General Recipe (EC GR)
· Provides feedback on equipment classes for incorporation into EC GR libraries
· Overseeing the creation of Functional Specification and Design Specification, Module testing, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) as well as conducting Integration testing (IQ) and Functional testing (OQ)
· Responsible for project management and execution
· Supporting ES related legacy systems
· Management of system interfaces as defined in the Execution System’s scope.
· Manages 24/7 system support (local execution, with option to elevate to Global platform level)
· Executes against global SOPs (including back up, disaster recovery, user administration etc.) and manage site specific work instructions
· Completes or participates in investigations (Events/CAPA's) for deviations related to ES systems
· Manages the provisioning of user defined reports and facilitate ad-hoc data queries
The site lead is accountable for:
· Overseeing activities of ES site engineers and recipe management specialists
· Creates and maintains lifecycle documentation management for local applications
· Local ES system data performance monitoring
· Participation in compliance inspections for topics related to ES systems
· Implementation & maintenance of network configuration (in partnership with IT)
· Providing (User) training to end users and system admin
· Overseeing activities for the creation of Master Recipe within the Control System and/ or MES
· Ongoing management of expectations and highlight site specific requirements versus required global ES standardization
· Provides feedback to Platform leads about site needs and priorities related to execution systems activities
· Ensuring that ES systems are fit for intended use and compliant with internal standards and applicable regulations
· Motivates and inspires site team to drive significantly increased performance through technical innovation and change. Provides leadership and development to the team and ensures there is a diverse pipeline of high performing multi-skilled leaders of the future.
· Drives a Credo-based culture aligned around our guiding principles of servant leadership, Think Differently, Do Better, innovation, engagement, collaboration and development.
· Handles all aspects of managing personnel, including hiring and terminations. Provides coaching and development opportunities. Evaluates performance and provides feedback. Implements disciplinary actions, as necessary.
· Ensures compliance in all aspects of Environmental, Health, Safety and Sustainability (EHSS) per Johnson & Johnson standards.
· A minimum of a Bachelor's degree in Engineering, a Science or a related discipline is required. Master’s degree in a Science or Engineering discipline or MBA is preferred.
· Experience working in a regulated industry is required.
· Required minimum of 6-8 years of experience in GMP or GLP regulated and related position, demonstrating increased leadership assignments and responsibilities
· Understanding of production process management is required
· Understanding of the business drivers within the site and platform and ability to translate them into measurable objectives for strategic programs is required.
· Demonstrated results leading, coaching and managing change that serves to motivate and inspire a highly engaged workforce to significantly improve performance, achieve stretch goals and solve problems.
· Must have a proven track record of developing technical talent.
· Leadership experience is required.
· Experience delivering innovative technical and engineering solutions in manufacturing environments is required.
· Knowledge of industry standard, guideline and methodologies ( NIST , ISA 88/95/99, GAMP)
· Knowledge of Process Excellence tools (Lean, Six Sigma) preferred. Green or Black Belt Certification in Lean or Six Sigma is preferred.
· Knowledge of technology development and validation, including design of experiments and statistical analysis, is preferred.
· Must have the ability to assess and mitigate technical risks.
· Familiarity with IT application design and deployment is preferred.
· Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
· Must have excellent verbal and written communications skills.
· Must have strong decision making and problem solving skills.
· Must have the ability to think strategically and manage change.
· The ability to collaborate effectively with all levels of management and drive alignment is required.
· The ability to work in a (global) platform matrix organization.
· This position will require up to 10% domestic and international travel.
Janssen Pharmaceutical K.K. (7195)