Responsible for process engineering and project management to support improvement of existing processes, and introduction of new products and processes. These projects are typically higher level capital projects with increased complexity, and can pose significant risk to product and processes if not designed and implemented correctly. Responsible for Project management, process development, process improvement, IQ/OQ/PQ validations, and Manufacturing process troubleshooting. Must be able to manage the project in its entirety, and be able to perform / deliver specific project tasks as necessary. Performs validation engineering and validation process related tasks for a FDA regulated manufacturing operation. Involves working with a team for the validation related tasks and establishing framework for those activities. Responsible for analysis and upgrade of utility systems when needed (WFI, DIUF, HVAC, CCA, and steam generation). Knowledge in CO2 incubators, refrigerators and freezers, Clean Rooms both ISO and EU standards, BSC's, bioreactors, and autoclaves . Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. Provide daily analytical and technical support to meet manufacturing objectives. Assemble and lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs. Lead teams in performing and updating Process FMECA risk management Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities Coordinate specific efforts of the project team, including the core team members (Manufacturing, Plant QA/QC/RA, Facilities, Materials Management, and Engineering) and supporting members (Corporate Regulatory, Finance, etc.). Includes such tasks as development of Manufacturing requirements, accounting documentation, specifications, validations, and Engineering drawings and ECN paperwork. Ensure that all appropriate documentation, drawings specifications are generated in compliance with Integra's procedures and statutory requirements (US FDA and ISO) Provide technical input for analysis of process changes Develop P&ID and PFD as required
Controls and automation, automation systems, gmp, gmp environment, Process improvement, Lean manufacturing, Continuous improvement, Process engineering, Lean six sigma, Process control, Manufacturing process
1) Exp and knowledge in validation engineering, specifically driving validation projects for manufacturing environments. 2) Experience in FDA and Biotech/ pharma 3) Experience in electrical engineering and analog/ digital systems.
BS in Engineering discipline (Chemical, Mechanical, Controls and/or Biotech,). Minimum of 5+ years' experience in maintenance of processing equipment and instrumentation in the pharmaceutical, biotechnology, or related industry. Strong facilities technical problem-solving abilities. Good understanding of PLC & automation Background in metrology an advantage. Experience in working within a quality management system. Experience of equipment validation, calibration and performing risk assessments. Knowledge of FDA regulatory requirements. AutoCAD and/or SolidWorks experience preferred.
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