Senior Manager, DR/BC, IT QA, and Process Improvement

Details: Astellas is the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Come, shine with us!Astellas is announcing a Senior Manager, DR/BC, IT QA, and Process Improvement opportunity in our Northbrook, IL location.This key leadership position is responsible for the IT Disaster Recovery/Business Continuity/Crisis Management, IT QA, and for process improvement projects within IT. Own and implement Disaster Recovery processes and strategies to ensure the security and integrity of data, data systems, and data networks across the organization. This includes re-establishing servers, applications, databases and operating systems in the event of a disruption, whether minor or catastrophic.Responsible for the Disaster Recovery Plan and overall strategy along with executing the disaster recovery plans and tests for Astellas's applications. Develop and mature the IT Disaster Recovery planning processes, including the strategy, approach, plans, and resources.Develop, maintain, and lead Crisis Management planning and execution.Facilitate the cross-functional activities necessary to conduct Business Impact Assessments for all applications with IT business partners and third-party vendors.Work with internal IT teams and PMO to ensure that policies, procedures, and tools are integrated into Disaster Recovery processes. Manage the creation of program status communications to internal management and external stakeholders regarding the status of the IT disaster recovery program, including annual reporting, audit report responses and customer requests.Provide PMO support with quality assurance of deliverables and overall support.Drive and own process improvement initiatives utilizing best practice process methodologies.Bachelors Degree in Computer Science or Business, or equivalent experience required. Masters Degree preferredMinimum 10+ years of related experience required, pharmaceutical industry preferredMust have excellent interpersonal and communications skills in order to effectively relate to internal and external professionals Vendor management of external Disaster Recovery service providersAt least two years experience in Business Continuity Management, QA, and Process Improvement MethodologiesExperience in defining, implementing and enforcing risk-based standards, processes and procedures for responding to disruptions in business or IT operationsProven competency in executing large projects, on time and within budget, with business and IT personnelProven ability to work under stressful conditions, such as business-related crises•cb*

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Process Quality Engineer (11192)

Details: Develop process plans that are cost effective, thorough, poka-yoked and that follow safe processes and practices.  Lead process optimization, quality improvements and continuous improvement activities for the shop floor (machining and assembly).  Assist with the justification and implementation of capital equipment and cost improvement programs.  Provide daily support to the shop floor in resolving process and quality issues by implementing effective corrective and preventative actions.  Develop and maintain shop floor procedures and documentation and ensure they are being followed on a daily basis.  This position is also responsible for the development and implementation of processes involved with new product introduction as well as with existing products.  This includes working with Manufacturing Teams, Quality Engineering and Design Engineering to facilitate the introduction of new products or the improvement to existing products and processes.Establish robust, effective, manufacturing and assembly processes with the appropriate measures for control, including, but not limited to process capability evaluations, statistical process controls, PFMEA’s, poka yokes, PM’s, JSA’s, etc..  These processes shall also maximize the utilization and efficiency of both capital equipment and direct labor. Lead and solicit suggestions and input from all team members for continuous process improvements (Kaizen Events, I@W, etc.).Implement and maintain Standard Work for manufacturing processes including, but not limited to, the development of the process, the output expectations, and cost effective packaging.  Audit work areas to sustain appropriate manufacturing methods.  Provide shop-floor support on process and quality problems.  Provide leadership in coordinating resolutions with other internal functions (Quality, SCM, Engineering, Sales, etc.). Develop, implement, evaluate and review training plans of operators to assure work instructions and safe methods are being followed, as well as to ensure satisfactory efficiencies.  The process engineer will also participate in the piggy-back training and evaluation of the trainee.Design Review representation for manufacturing.  Review new product design(s) for manufacturing tooling, standards and capabilities.  Recommend design changes for manufacturing and cost effectiveness in support of value engineering.  Represent Manufacturing in Configuration Change Control Board (CCCB) activities.Estimate manufacturing costs on new products.  Establish and maintain time standards and standard data elements for processes and equipment.Investigate customer complaint(s), verify root cause and implement/verify and communicate corrective actions.Support or assist in audit activities (internal (quality, 5S, safety), customer and governing agencies) during evaluation of NYAB.Provide daily leadership to the shop floor.  This position will assume supervisory responsibility in the absence of the production supervisor.

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Process Quality Engineer (11192)

Details: Develop process plans that are cost effective, thorough, poka-yoked and that follow safe processes and practices.  Lead process optimization, quality improvements and continuous improvement activities for the shop floor (machining and assembly).  Assist with the justification and implementation of capital equipment and cost improvement programs.  Provide daily support to the shop floor in resolving process and quality issues by implementing effective corrective and preventative actions.  Develop and maintain shop floor procedures and documentation and ensure they are being followed on a daily basis.  This position is also responsible for the development and implementation of processes involved with new product introduction as well as with existing products.  This includes working with Manufacturing Teams, Quality Engineering and Design Engineering to facilitate the introduction of new products or the improvement to existing products and processes.Establish robust, effective, manufacturing and assembly processes with the appropriate measures for control, including, but not limited to process capability evaluations, statistical process controls, PFMEA’s, poka yokes, PM’s, JSA’s, etc..  These processes shall also maximize the utilization and efficiency of both capital equipment and direct labor. Lead and solicit suggestions and input from all team members for continuous process improvements (Kaizen Events, I@W, etc.).Implement and maintain Standard Work for manufacturing processes including, but not limited to, the development of the process, the output expectations, and cost effective packaging.  Audit work areas to sustain appropriate manufacturing methods.  Provide shop-floor support on process and quality problems.  Provide leadership in coordinating resolutions with other internal functions (Quality, SCM, Engineering, Sales, etc.). Develop, implement, evaluate and review training plans of operators to assure work instructions and safe methods are being followed, as well as to ensure satisfactory efficiencies.  The process engineer will also participate in the piggy-back training and evaluation of the trainee.Design Review representation for manufacturing.  Review new product design(s) for manufacturing tooling, standards and capabilities.  Recommend design changes for manufacturing and cost effectiveness in support of value engineering.  Represent Manufacturing in Configuration Change Control Board (CCCB) activities.Estimate manufacturing costs on new products.  Establish and maintain time standards and standard data elements for processes and equipment.Investigate customer complaint(s), verify root cause and implement/verify and communicate corrective actions.Support or assist in audit activities (internal (quality, 5S, safety), customer and governing agencies) during evaluation of NYAB.Provide daily leadership to the shop floor.  This position will assume supervisory responsibility in the absence of the production supervisor.

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