SME Engineer (Jobs in Bloomington, IN)   Requirement id 100779 Job title Engineer Job location in BLOOMINGTON, IN Skills required Word And Excel, Bachelors Degree, SME, Open Date 02-Dec-2019 Close Date Job type Contract to Hire Duration 5 Months Compensation DOE Status requirement not found Job interview type Face to Face interview    Email Recruiter: coolsoft Job Description Engineer: Word And Excel, Bachelors Degree, SME, Note: * Candidate must be your W2 Employee. * We should submitt only GC, GC EAD, L2 EAD, H4 EAD and Citizen. * We should take signed RTR form from the candidate (Candidate RTR form should be only on the name of Apex Systems) Job Description : Summary The Packaging Validation Associate III supports all aspects of pharmaceutical packaging equipment, including equipment design, specification development, installation, qualification, validation and operational support. This role serves as a resource and subject matter expert for automated inspection machine equipment and high speed packaging equipment. This position reports to the Manager, Packaging Validation. Essential Duties and Responsibilities: * Identifies and implements necessary changes to automated inspection lines (including automated inspection machines, labeling equipment, blistering equipment, cartoning machines, and serialization equipment) * Performs validations of automated inspection machines for syringes, vials, and cartridges, including development of vision files for particle sensors and for inspection cameras * Performs validations of automated packaging lines (including labeling equipment, blistering equipment, cartoning machines, and serialization equipment) * Manages multiple projects providing technical support for packaging operations while working in a cross-functional team environment * Serves as subject matter expert (SME) on automated packaging lines and automated inspection machine validations (Eisai machines) * Develops Validation documentation including Process Flow Diagrams, Failure Mode Effect Analysis (FMEAs), Protocols, Final Reports, etc. * Assists Engineering Department on Factory Acceptance Tests (FAT) and User Requirement Specifications (URS) * Leads small project teams to accomplish project objectives, including creating timelines, tracking deliverables and communicating status updates to key stakeholders * Formulates and recommends test procedures and technical work in accordance with project and business objectives * Utilizes Engineering and Quality tools to solve problems (e.g., FMEA, Design of Experiments) * Evaluates packaging components in terms of functionality and machinability; develops Bill of Materials (BOM), Packaging Component Specifications and Packaging Process Assembly Specifications * Creates Project timelines and develops all related packaging equipment validation documentation * Maintains up to date knowledge of industry requirements and practices as they relate to packaging equipment * Participates in internal, external, and pharmaceutical client audits and tours * Acts as Change Control Management (CCM) Owner * Reviews and Approves batch record documentation, validations, and SOP workflows * Serves as designee to Manager, Packaging Validation * Mentors less experienced team members * Authors and supports investigations related to packaging Job Requirements (Education and Experience) * Bachelors Degree required; science or engineering related area preferred * Minimum of 5 years experience in validation-related activities working in a CGMP environment is required * Background in electro mechanical operations required * Experience in Machine Vision preferred (Cognex software such as Vision Pro or Insight is desirable) * Background in validation (IQ/OQ/PQ) including study design, and the development of Protocols, Final Reports, and SOPs etc. preferred * Certified Packaging Professional (CPP) certification preferred * Proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Trackwise, etc.)   Call 502-379-4456 Ext 100 for more details. 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