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This is Harry from Dynamic Enterprise Solutions. We have urgent requirement with one of our client’s, please review below job description and let me know your interest Position Id: DYES00010988 Job Title: Sr Quality Engineer/Senior CAPA Exception Documents Specialist Location: North Chicago, IL Length of assignment: 1 year Locals Only Job Description Purpose: Performs and documents GMP root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for R&D clinical drug product manufacturing and packaging. Develops, documents and tracks to completion corrective and preventive actions (CAPA) to prevent nonconformities from occurring again. Performs other compliance related tasks to support the business, such as authoring change requests to operating procedures, providing support for internal and customer audits and reviewing logbooks, batch records, etc. for accuracy and completeness. Holds regular CRB and IRB meetings and monitors tasks to ensure timely completion. Responsibilities: * Extensive technical writing capability for exception document and investigation drafting * Responsible for consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements. * Coordinate the exception document process and write exception documents. * Ensure that all investigations are written according to corporate, division, and local requirements Qualifications * Required: Bachelor’s Degree or equivalent experience * Preferred: BS plus 7 years GMP experience or MS plus 5 years GMP experience NOTES FROM THE MANAGER: 1) What hours and days will this person be working? Day shift Monday through Friday with expectation to come on site to perform initiation information collection for investigation if nonconforming event happens during off shift hours. 2) What are the top 5 skills/requirements this person is required have? a. Required Skill 1: Performs and documents GMP root cause investigations for exceptions/nonconformities/deviations b. Required Skill 2: Develops, documents and tracks to completion corrective and preventive actions (CAPA) to prevent nonconformities from occurring again c. Required Skill 3: Extensive technical writing capability for exception document and investigation drafting d. Required Skill 4: Responsible for consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements e. Required Skill 5: Coordinate the exception document process and write exception documents 3) What years of experience, education, and/or certification is required? Bachelor’s Degree or equivalent experience 4) What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? BS plus 7 years GMP experience or MS plus 5 years GMP experience, prefer previous experience in GMP manufacturing or quality settings 5) What is the environment that this person will be working in (i.e. group setting vs individual role)? Person will work as individual contributor mostly, there is another CAPA writer on site but each CAPA writer is expected to lead their own investigation cases 6) Is any testing required for this role? Nothing on top of regular background and drug screen 7) Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? This is an on-site required role 8) Other notable details about the environment from the hiring manager about this role: CAPA writer will be working in GMP regulated production area performing exception reporting/investigation. Prolonged sitting in front of a computer during document write up 9) What positions/background experience do you feel are successful in this role: QA specialist, CAPA specialist, CAPA coordinator, QA engineer Position ID: ABOJP00011998 Title: Software Python scripter Location: Waukegan, IL Duration: 12 Months+ Locals Prefereed Job Description & Required Skills Exact start date will be determined when a candidate is selected. This is an urgent request. Please use the following: Software Python scripter; Python version 3.8. Senior Software Engineer with 10+ years experience in coding and script work using python language and embedded code using c language. Candidate will have experience with controlling servo motors including Teknic driver parameters, stepper motors including PMD drivers, actuators, valves, pumps, and be able to craft scripts to process critical timing steps of complex medical devices. Able to understand limitations of mechanisms and develop & troubleshoot code to process thermal and fluidic control systems. Position ID: DYESFK001726-1 Title: SAP EWM Business Analyst Location: Lake Zurich, IL Duration: 3-6 Months+ Locals preferred Primary Responsibilities: This Contractor Position is to add more capacity for short term with SAP Functional Senior Business Analysts on IT SAP team due to various Projects and Production Support needs. Persons should understand current EWM set up and support Go‐Live and hyper care at our manufacturing sites. Main liaison to business functional areas - Partnering with business stakeholders, understanding their needs, prioritizing efforts, recommending changes / innovations, serving as the Subject Matter Expert for their area of expertise. System Design - Documenting requirements and developing solutions using standard or custom SAP functionality. Recommending alternatives when multiple options are available. Developing Solutions - Performing SAP System Configuration, writing functional requirements for custom development, performing appropriate system tests (Unit Testing, Regression Testing, User Acceptance Testing), writing system/user documentation, training end users on functionality. Production Support - Troubleshooting system issues, analyzing processes, recommending course of action. Specific Skills and/or knowledge, credentials, or professional certifications: In depth functional and configuration expertise in SAP EWM as a separate instance utilized by multiple SAP ECC instances. Experience in multiple end to end EWM implementations in a production environment. Analytical skills must include the ability to quickly identify problems, gather relevant information, determine the root causes, and make recommendations regarding solutions. Proactive, self‐starter who sets high standards for self and co‐workers. Strong organizational skills ‐ ability to manage multiple competing tasks and adapt quickly to changes. Excellent communication and interpersonal skills. Specific Skills/ Experience required: ・ Multiple end to end EWM implementation experience in a manufacturing production environment including Master Data cutover from an existing WM environment to an EWM environment. ・ Knowledge and experience in Advanced production integration. ・ Experience in working with EWM interfaced to ME (manufacturing execution) systems. ・ Hands on experience in EWM Warehouse internal movements, inventory management, cycle counting, RF, RFID and PPF Configurations. ・ Hands‐on experience working on SAP EWM inbound and outbound configuration and processes. ・ An understanding and work experience in Warehouse processes in a logistics execution area. ・ Extensive experience on POSC/LOSC and Returns process, Batch Management and Serialization. ・ Have a good functional understanding about SCM‐EWM processes with integration of MM, PP and QM: ・ The ability to monitor and troubleshoot queues and failed entries ・ Should be on-site for providing Go-Live and hyper care support Skills a plus: ・ Experience in working with ASRS (Material Flow systems) integrated with EWM. ・ Experience in interface with QM‐IDI and ERP systems. Position Id: DYES00010964 Title: Digital Systems LIMS ( Laboratory information management system) Location: Worcester, Massachusetts Duration: 6-12 months+ Description: Exciting opportunity to be part of a digital transformation journey for our Science & Technology product development and QC laboratories through the enablement of new solutions that delivers an integrated platform that will allows our scientists make smart data driven decisions. Requirements: * Required - experienced deploying SCADA / OSIsoft PI / OPC and integrating laboratory equipment. * Required - Experience integrating instruments, applications, and peripherals in a GxP lab environment, with applications such as Smartline Data Cockpit, and OSIsoft PI and OPC. * Preferred experience implementing lab informatics and visualization - eg Spotfire, QlikSense, JMP, Python, VB * Preferred - Knowledgeable in lab instrument software and applications such as ATKA Unicorn, Agilent HPLC, OpenLAB ECM, ChemStation, Empower * Application knowledge should include system administration experience and implementation of new software releases. * Candidate needs to be able to develop application solutions. * Experience in validating lab systems in GMP environment. * Good understanding of operating systems, networking components, data integrity, data security and database structures. * Works effectively with team/group to accomplish organizational goals. Education: * Bachelor’s degree preferred in Engineering, CS, or a relevant discipline; 5+ years of related experience. Accountability: * The individual works under the direction of subject matter experts within Digital Systems. * Determines business objectives of assignments and contributes to the design of systems, programs, and processes; completes project tasks within time and budget constraints. Scope of Work: * Provide system and validation support for projects and ongoing activities supporting Digital Systems - Lab Systems group. * Design and develop systems and informatics solutions in support of Development and Quality Labs * Responsible for validation activities associated with lab systems in a GxP environment. * Provide system administration to the lab applications. * Provide analysis and problem solving - Applies analytical thinking skills to diagnose and make recommendations on system issues. * Provides end user support for lab applications and systems (tier 1 and 2). Works with corporate and vendor support teams to drive issues to resolution. Position ID: DYES00010982 Title: OCM Service Delivery Management Project and Program Delivery Location: North Chicago, IL Duration: 6 Months+ Description: Primary Needs: * Position will reside within the Innovation, Architecture, and Infrastructure team at AbbVie. * Project Manager will lead one of 2 projects: o AbbVie/Allergan Service Desk Managed Service Provider (MSP) Integration o AbbVie/Allergan Site Support Managed Service Provider (MSP) Integration * 2 resources are required for this posting, 1 per project. Both projects require a similar skill set/role. One will cover Service Desk and one will cover Site Support (aka Desktop). * Strong project management skillset, including proven ability to lead and drive project success. * Strong collaboration and communication skills given the high degrees of change, project complexity, and potential senior executive interactions. * Responsibilities will include: o Work directly with the MSP-assigned integration/transition PM to ensure project progression, raise/mitigate risks, and drive successful and timely completion of the project. o Assist the existing Senior Project Manager in the MSP Consolidation Service Desk/Site Support project planning and execution o Assist the existing Senior Project Manager and Project Sponsor in documenting current vs. future state, as well as the new consolidated processes with respect to AbbVie's Global Service Desk and Site Support (Service Now Incident and Request changes, Knowledge Creation to support the consolidation work, OCM and training work tied to the consolidation, Hypercare needs, Service Desk and Site Support's role in migrations, etc.) o Responsible for leading weekly status and ad-hoc project-related meetings, e.g. planning and requirements gathering, training, cross-functional sessions, etc. o Responsible for updating the project status in Clarity PPM on a weekly basis o Responsible for documenting detailed project execution tasks, assigning resources to those tasks, and following up with resources to drive to completion o Responsible for coordinating meetings with other cross-functional groups and/or Service Desk/Help Desks where AbbVie Global Service Desk and Legacy Allergan Service Desk have touch points o Assist Senior Project Manager with documenting project risks, issues, dependencies, assumptions, and constraints o Escalate any issues and/or roadblocks to the Senior Project Manager and Project Sponsor * Will work with a matrixed team, and two MSPs (current AbbVie and legacy Allergan). These MSPs will need to be managed as we transition/integrate services. * Contract to run from candidate’s start date through end of March 2021, with extension available following proven performance. * Will execute and deliver in line with below expectations. Expectations: * Develop, execute, and manage project(s) within the defined scope. * Lead all aspects of the project lifecycle, working with project sponsors/key stakeholders, team members, and management to oversee all phases of project completion. * Build and manage project’s work breakdown structure, milestones, risks, issues, and deliverables within the constraints of human and financial resources and changing priorities to ensure the successful completion of the project. * Ensure transparent reporting of project status, issues, risks, and financials. * The individual will rely on experience and judgment to plan and accomplish goals. * Performs a variety of tasks. * May lead and direct the work of others. * Be able to work under general supervision. * A certain degree of creativity and latitude is required. Specific Responsibilities: * Initiate and Plan Project: Works with business and IT management to establish and gain consensus on project goals, objectives, financials, and deliverables. * Project Control: Assess the degree to which changes to scope, issues and risks will affect the project, working with business and IT management and sponsor to gain agreement for resolution. Measure performance to assure the project is progressing as compared to original plan and budget. * Executing and Closing Project: Develops and executes a work plan obtaining authorized resources to ensure all activities are performed. Leads team in delivering project scope. Gather lessons learned and obtain final project approval from sponsor and stakeholders. * Project Communication: Communicate project progress by producing project reports to provide timely and accurate project status and decision support information to project teams, business, and IT management. Makes recommendations based on current project status to resolve issues and manage risks. * Resource and Team Management: Coordinate resources to ensure project needs are addressed and effectively assign tasks and deliverables to team members based upon their abilities. Motivates project team to deliver project outcomes. * Quality Management: Responsible for compliance with applicable Corporate and functional policies and procedures. * Decisions: Make decisions that impact project level activities. Qualifications: * Primary Needs on page 1. * 8 years of project management experience. * PPM Tool experience a must. * Individual must be able to work full time; will initially work in a remote setting, with transition to on-site in Lake County, at a date to-be-determined. Preferred Qualifications: * Experience with using Clarity PPM. * Familiarity with Organization Change Management experience/knowledge. * PMP Certification. * Pharma Experience. Position ID: DYES00010925 Title: Infrastructure Engineer/ Data Architect Location: North Chicago, IL Duration: 6 Months+ Locals preferred Description: AbbVie Operations is seeking a motivated self-starter to join the Business Technology Solutions (BTS)/Data Analytics Team. This team is a dynamic group of IT, Automation Operation Technology (OT), and Business specialists who work together to deliver manufacturing software solutions, drive standardization, innovation, optimization, identify requirements for future enhancements. The team is looking to add knowledgeable site IT/OT/Automation/Business subject matter experts (SME) to support the manufacturing operations, within an exciting time of multiple new product introductions and deployments, work directly with the business functions for optimization opportunities and represent these functions LRP and system enhancement planning. Sr. BTS OT Engineers/Analysts serve as liaisons between IT and operations, business, engineering, maintenance, and quality, and focus on business priorities/processes/ innovations as well as related data analytics. Requirements: * OSI PI Administration - Provide direct administration, development, and support of all aspects of the plant data historian, OSI PI, including interfaces to plant floor automation/control systems, as well as to higher-level Manufacturing Execution Systems/Business Systems. * Familiar with Windows Server/Client operation and support of applications (start/stop services, obtain windows logs, etc.), as well as solid understanding and experience with networking fundamentals of IP addressing, firewalls, routers, etc. * Moderate to advanced knowledge of plant floor automation control systems (PLC/DCS/SCADA) and controls engineering fundamentals, including experience with controls/automation systems integration, spanning legacy (hardwired/Modbus) to current (Ethernet IP/OPC UA). * Must have strong verbal and written skills and proficient in setting and managing customer expectation. * Can explain and present complex technical ideas to both technical and non-technical audiences at all levels up to the highest in a persuasive and convincing manner. * Use of vendor or industry sources to identify opportunities or problems. Produce data-driven impact analysis and incorporate into technology plans. * Uses appropriate tools to collect, correlate and analyze data; records and maintains technical data for use in developing operating and instruction manuals. Conducts tests; develops preliminary findings for review by experienced analysts. * Assists in the development of standards and procedures. Prepares written reports of work and conducts training. * Applies analytical thinking skills to diagnose and make recommendations on systems. Incorporates knowledge of business and technology to make recommendations. Translates data gathered from user discussions into business requirements. Identifies business/system needs and recommends solutions. Qualifications Desired skills: * Strong project management skills, including accounting/finance controls. * Engineering skills related to Electrical/P&ID drawing review, programming, specification development, etc. * Knowledge of pharmaceutical cGMP practices as they relate to IT/OT systems, including understanding of standards such as S88, S95, GAMP, and others * Relevant experience in manufacturing environments including bulk chemical/pharmaceutical processing and/or final packaging operations. Additional Job Functions: * Provides indirect support for other systems, such as POMSnet, SAP and other. Has large usage of these systems and requires a moderate MES/SAP knowledge/skill set. * Resolving technical issues and coordinating with appropriate groups within (i.e. Business users) and outside of the company (i.e. consultants, software vendors, etc.). Escalating issues as appropriate. * Leading effort to translate business requirements into business process, technical requirements and design specifications using industry standard tools and methodologies. * Understanding and promoting data governance, data reuse and good data management practices. * Evaluating, defining, and recommending solution alternatives to meet the business needs and maximize reuse. * Helping the business make business savvy decisions regarding risks, costs, measures of success, and financial justification, Return on Investment (ROI) by making informed tradeoffs during the solution definition process. * Providing input into business capability roadmap through partnership with business groups and maintaining technology roadmaps through partnership with solution and technology vendors. Coordinates and facilitates testing and end-user training. * Developing findings and preparing summary presentations for management review. * Using data analysis tools (i.e. Excel, Cognos, SQL, or other application analytic packages) to support reporting needs and resolve data issues. * Coordinating and facilitating project implementation and stabilization phases. * Achieve a satisfactory level of technical and professional skill or knowledge in position-related areas, keeping abreast of current developments and trends in area of expertise. * Understand internal and external business dynamics, business process complexity and business implications. * Ability to perform solution alternative analysis, vendor evaluation and articulate risks and financial benefit. * Ability to understand technology trends and utilization of new or existing technology. * Have technical awareness to analyze trends and outputs (i.e. defects and enhancements). * Ability to evaluate all aspects of impact - business process, data analysis, reporting and analytics. * Responsible for compliance with applicable Corporate and Divisional Policies and procedures. * Analyzes departmental processes and needs, makes recommendations that are most effective means to satisfy those needs. Analyses the most complex work procedures and job methods and presents concepts to simplify those procedures. * Works effectively with team/group to accomplish organizational goals. Actively participates in client or team meetings by offering suggestions. Provides leadership to project planning. Thanks & Regard’s Harry John Dynamic Enterprise Solutions Inc 1801 Hicks Rd, unit A Rolling Meadows, IL -60008 (847) 719-7902 /(c) 224-635-0898 Email: [email protected] -- You received this message because you are subscribed to "rtc-linux". Membership options at http://groups.google.com/group/rtc-linux . Please read http://groups.google.com/group/rtc-linux/web/checklist before submitting a driver. --- You received this message because you are subscribed to the Google Groups "rtc-linux" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. 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