Manufacturing Technology Specialist - Continuous Improvement
Company Name:
Placement Services USA, Inc.
To perform the following duties: As part of the Continuous Improvement team, identify, develop, implement, and sustain advanced technology introductions resulting in improved process efficiency, equipment utilization, and reduced operator intervention. Coordinate process improvements, technology introductions, and capital investments with other Engineering, Operations, Planning, and Quality departments per company policy and practice. Represent manufacturing within a cross-functional New Product Introduction team. Implement functional test equipment, hardware, software and procedures for testing of manufactured products. Support manufacturing and manufacturing engineering CAPA (corrective and preventative action) closure activities. Investigate MRBs, define root cause and drive solutions to correct and prevent reoccurrence. Adhering to FDA guidelines, enhance current manufacturing SOPs, Work Instructions, and Business processes that facilitate a culture of Continuous Improvement while maintaining a state of compliance to regulations. Drive improved product quality by identifying manufacturing issues, development of cost-effective solutions, and overseeing the successful implementation into production. Ensure regulatory compliance through generation of Equipment Qualification and Process Validation documentation. Create clear, concise documentation and visual standards for procedures and manufacturing processes. Work with Production Associates to resolve manufacturing and quality problems related to methods, processes, tooling, equipment and product design. Identify and drive cost reduction projects through the utilization of Lean Manufacturing principles thru improved tooling, automation, and reduced/combined production steps where possible. Train, or assist shop floor personnel in the use of programmable equipment and in the resolution of problems per processing requirements based on daily job assignments. Maintain compliance by executing internal policies, procedures and all related paperwork under ISO/FDA guidelines. Ensure that product, equipment, tools, processes, software, training and documentation meet requirements by thorough understanding of financial justification, document control, design transfer, verification, validation, acceptance, DMR, DHR, Quality Control and Inspection, and electronic record/electronic signature activities.
Work Schedule: 40 hours per week/8 a.m.-5 p.m./M-F.
3 years of experience in quality control and implementing automated control systems in a pharmaceutical and/or medical device manufacturing environment, plus demonstrated experience in: Project Management of Capital Equipment introductions, development of User Requirement Specifications, Functional Specifications, Factory Acceptance Test, Site Acceptance Tests and Test Protocols for manufacturing equipment; ability to specify, implement, and apply process automation control systems (PLCs, SCADA, HMI, Embedded Controllers), and materials handling equipment (Conveyors, Transfer Lines, AGVs, Robotics, Pick and Place, Vision Systems); to generate and execute protocols and requirements for Software Validation, using cGMP, SDLC, GAMP methodologies; and to apply various problem solving techniques (DMAIC, Ishikawa, Fault Tree, Pareto etc).
Bachelor's degree in controls engineering, or related field (or equivalent combination of education and/or experience)
Please send us your resume via email at with reference #231183 in the subject line. Do not copy and paste your resume in the body email. Please attach it as a Word document. Thank you.Estimated Salary: $20 to $28 per hour based on qualifications.
Placement Services USA, Inc.
To perform the following duties: As part of the Continuous Improvement team, identify, develop, implement, and sustain advanced technology introductions resulting in improved process efficiency, equipment utilization, and reduced operator intervention. Coordinate process improvements, technology introductions, and capital investments with other Engineering, Operations, Planning, and Quality departments per company policy and practice. Represent manufacturing within a cross-functional New Product Introduction team. Implement functional test equipment, hardware, software and procedures for testing of manufactured products. Support manufacturing and manufacturing engineering CAPA (corrective and preventative action) closure activities. Investigate MRBs, define root cause and drive solutions to correct and prevent reoccurrence. Adhering to FDA guidelines, enhance current manufacturing SOPs, Work Instructions, and Business processes that facilitate a culture of Continuous Improvement while maintaining a state of compliance to regulations. Drive improved product quality by identifying manufacturing issues, development of cost-effective solutions, and overseeing the successful implementation into production. Ensure regulatory compliance through generation of Equipment Qualification and Process Validation documentation. Create clear, concise documentation and visual standards for procedures and manufacturing processes. Work with Production Associates to resolve manufacturing and quality problems related to methods, processes, tooling, equipment and product design. Identify and drive cost reduction projects through the utilization of Lean Manufacturing principles thru improved tooling, automation, and reduced/combined production steps where possible. Train, or assist shop floor personnel in the use of programmable equipment and in the resolution of problems per processing requirements based on daily job assignments. Maintain compliance by executing internal policies, procedures and all related paperwork under ISO/FDA guidelines. Ensure that product, equipment, tools, processes, software, training and documentation meet requirements by thorough understanding of financial justification, document control, design transfer, verification, validation, acceptance, DMR, DHR, Quality Control and Inspection, and electronic record/electronic signature activities.
Work Schedule: 40 hours per week/8 a.m.-5 p.m./M-F.
3 years of experience in quality control and implementing automated control systems in a pharmaceutical and/or medical device manufacturing environment, plus demonstrated experience in: Project Management of Capital Equipment introductions, development of User Requirement Specifications, Functional Specifications, Factory Acceptance Test, Site Acceptance Tests and Test Protocols for manufacturing equipment; ability to specify, implement, and apply process automation control systems (PLCs, SCADA, HMI, Embedded Controllers), and materials handling equipment (Conveyors, Transfer Lines, AGVs, Robotics, Pick and Place, Vision Systems); to generate and execute protocols and requirements for Software Validation, using cGMP, SDLC, GAMP methodologies; and to apply various problem solving techniques (DMAIC, Ishikawa, Fault Tree, Pareto etc).
Bachelor's degree in controls engineering, or related field (or equivalent combination of education and/or experience)
Please send us your resume via email at with reference #231183 in the subject line. Do not copy and paste your resume in the body email. Please attach it as a Word document. Thank you.Estimated Salary: $20 to $28 per hour based on qualifications.
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