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Job Title:Manufacturing Engineering Technician Departments:EngineeringGrade:10 - ExemptReports to:Sr Engineer or Engineering ManagementDate:October 2020Purpose:Provide ongoing commercial process support on all rotary die cutting and packaging production lines. Assists the Manufacturing Engineers on process transfers from development to commercial, assisting in continuous improvement (CI) initiatives, training of production operators and maintenance staff, and support of equipment install/qualification/start-up. Support the portfolio of TM products and projects in accordance with cGMP, FDA, and DEA regulations and standards.Principal Responsibilities:Assist and troubleshoot process / equipment issues that occur during commercial operations and product changeovers. Including utilization and adjustments of Vision System programs and tools.Assist in Design Reviews and contribute to activities in the improvement of commercial slitting, converting, packaging, cartoning and serialization processes for transdermal, dissolvable films and other drug products.Assist in equipment / product qualification testing.Contribute to Continuous Improvement (CI) activities that increase efficiencies, quality, yields and/or reduce costs.Support and follow all regulatory compliance aspects, including following the necessary change control processes.Generate / review / update documentation, from an engineering perspective, as it relates to protocols, batch records, reports, FMEAs, SUDs, drawings, and others. Perform data entry and analysis using various statistical tools as needed. Provide technical guidance to operations via training / mentoring and process troubleshooting when appropriate.Assist in receiving the hand-off of developed processes from R&D with robust process controls and shepherding through Validation and into Commercial product phases.Assist in design / re-design of tooling, parts, and equipment for use in various projects.Other duties as assigned.Job Qualifications:Ability to review large amounts of data/information, identify trends, draw conclusions and support a position with text and data.Minimum 3 years hands-on experience in pharmaceutical or medical device manufacturing operations, preferably with transdermal and oral dissolvable thin film products, OR, experience with pressure sensitive adhesive processes for medical or other applications. Strong computer experience in excel spreadsheets, graphing, word-processing, simulations, and other software analysis programsHighly motivated individual who can work both independently and as part of a cross-functional team.Demonstrated problem-solving and analytical skillsMust be able to effectively communicate results or issues, verbally and in writing.2-year Technical Degree in relevant field.Preferred Qualifications:4-year Degree in Engineering or Science based discipline.Knowledgeable and experienced on cGMP and FDA manufacturing requirements. Demonstrated experience updating Manufacturing Records, SOPs, Set up Diagrams and additional protocols Knowledgeable in Vision System adjustments. Employee Signature: __________________________________Date: ________________________ ................
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