Primary function are Manufacturing processes and equipment automation / control technical support including problem resolution, originate, justify and implement projects to improve the productivity, reliability and maintainability of the production equipment, reduce rejections and waste, improve product quality and reduce cost. Responsible of the calibration area including internal and external resources. Job Description RESPONSIBILITIES: Troubleshoot and develop automation controls for utility and manufacturing equipment including ladder logic, high level language or any other control software application. Lead Projects and / or act as an integral member of project teams tasked with resolving technical issues or continuous improvement projects utilizing Six Sigma and Lean Manufacturing. Conceptualize, develop, investigate and troubleshoot automation of manufacturing utility equipment. Develops workable project plans and timelines and successfully leads project team to meet goals. Readily identify and analyze problems and generate effective courses of action. Independently apply scientific principles to achieve project objectives, including the design and execution of experiments and the analysis and interpretation of results. Perform tasks according to existing protocols and adapt protocols to new situations as required, in a GMP/GLP environment. Responsible of the plant calibration program and the technical resources. Insure plan calibration system and programs are maintained in accordance to policy and industrial standards Collects, records, reports, and interprets data in a manner consistent with QSR, ISO, and GMP guidelines. Presents results to team members and leadership orally and in writing. Performs work independently with a minimum of Managerial input Support the day to day manufacturing and utility operation. Interacts with others with QA, Media Manufacturing, R&D and other functions within local and corporate BD, and with external customers, vendors and suppliers. Participates in other assignments such as projects, investigations, meetings, presentations, company representation, etc., as directed by management Support activities to comply with the Department and company metrics (Individual Impact Goals, Score Card) Keeps his/her immediate manager informed of all significant conditions and plans relating to assigned responsibilities.Responsible for the compliance to FDA/ISO 9000/ ISO 14000, safety Regulations and Company Policies/Procedures within his/her group. Generate and execute validation protocols of new or modified equipment (IQ/OQ/PQ). Project support including writing protocols, specifications, Request for Proposal, User requirements, project schedule, etc. Provide support in the analysis and resolution of the CAPA, QN, and Notification related issues POSITION REQUIREMENTS Education: Bachelor Degree in Mechanical or Electrical Engineering EIT license Member of PR Professional College of Engineers and Land Surveyors (CIAPR) Knowledge and Experience: Requires three years of automation/instruments control experience in a regulated industry such as Medical, Pharmaceutical or related industry. Requires Project management knowledge including training and tools such as MS project, Primavera, Excel. Knowledge in the following: PLC Programming, Allen Bradley, RS Logic, Ladder logic, visual basic or C++,Preparation and testing of SCADA, instrumentation. Programming in all above areas. Conducting FAT, SAT,IQ, OQ, PQ, and Engineering Study Experience on computer system validation. Experience in problem solving and troubleshooting is required. Experience in process development utilizing automated manufacturing equipment within a regulated (GMP / QSR) industry desired. Experience in analysis of manufacturing processes, development of process improvements, and validation of process changes desired. Experience with processes including fluid dispense and filling, labeling, packaging and utilities. Effective communication and interpersonal skills. Ability to work within a team environment, ability to lead a project team, and ability to prioritize responsibilities required. Computer Literate (Windows, Internet, MS Office (Word and Excel) and related programs) Fully bilingual, Spanish-English. Financial knowledge such as Budget and cost analysis are a plus. Supervision: Functional supervision of Calibration Technicians. Mental or Visual Demand: Needs to apply principles of logical or scientific thinking to define problems, collect and analyze data, establish facts and draw valid conclusions. Interprets drawings and technical instructions furnished in written or oral form. Prepares business letters, expositions, summaries and reports, using standard formats and conforming to rules of punctuation and grammar. Participates in panel discussions, prepares and delivers presentations. Conduct training sessions. Communicate verbal instructions and requirements in clear, effective manner. Physical Demand: Work is mainly sedentary in office environment including walking and standing to visit production or project areas.
