KBI Biopharma Senior Automation Engineer in Boulder, Colorado
This position is responsible for providing system administration, day to daysupport and maintenance of the KBI Boulder site Manufacturing Automationsystems. This work will include working independently with ManufacturingOperations, Quality, Outside Contractors, site IT and ManufacturingScience groups. Support the automation and light process engineering for newproduct introductions, identifying and implementing continuous improvementchanges in addition to providing system administrative services. The positionmay include, night and weekend work as well as on-call coverage.Responsibilities:Provide Automation improvements based on Good Manufacturing Practices(cGMP's), particularly as they relate to the operation, validationand maintenance of manufacturing related computer Systems including 21 CFRPart 11 Electronic Records, Electronic Signatures.Manage the scope schedule and budget for small to medium sized Automationengineering projects in addition to the technical aspects of the project whenrequired.Troubleshoot and maintain, control system infrastructure including GE,Allen Bradley, and Honeywell.Lead the design, commissioning and implementation of control and automationengineering projects in cGMP manufacturing areas and supporting labs.Implement proposed automation changes through local quality systems includingChange Control and CAPA systems to meet the cGMP requirements of theseproposed changes.Responsible for project scope definition and construction management onAutomation project work conducted by internal personnel or contractedservices.Provide recommendations and assist with implementation of methods,procedures and techniques for improving Automation of existing and new systemsas well as assisting with system failure root cause investigations.Provides manufacturing support, troubleshooting, and atypical resolutionto ensure a consistent and reliable supply of products. Develops andexecutives short-term and long-term plans to implement corrective actions forAutomation based atypical events.Must be available to work occasional nights, weekends, holidays and toprovide 24 hour 7 days a week on-call support on a rotating basis.Use of equipment design documents, manuals and drawings to troubleshootproblems.The responsibilities of this position include hazardous and non-hazardouswaste handling.Qualifications:Education: B.S. in Engineering (Chemical/Mechanical/Electrical),or equivalent work experience.Experience:A minimum of 8 years of experience in the pharmaceutical industry inAutomation engineering.Proven knowledge of cGMP manufacturing processes and related codes andregulationsThorough knowledge of SCADA and PLC based control systems including GE andAllen Bradley platforms.KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversifyits work force. Therefore, all qualified applicants, regardlessof race, color, national origin, religion, gender, genderidentity, sexual orientation, age, disability or Vietnam veteranstatus, are strongly encouraged to apply.