Modis Engineering is currently recruiting for a Direct Hire Manufacturing Engineer job in Braintree, MA. To be considered for this position you must have at of 1-3 years of manufacturing engineering experience.
You will be responsible for providing manufacturing engineering services to support efficient drug and device manufacturing processes. Engineering services may include cell management, process development, project management, process validation, tool design, and trouble shooting.
Responsibilities for Manufacturing Engineer job include but are not limited to the following
Creating, maintaining, and improving controlled technical documents such as prints, procedures, bill of materials, routers and life cycle documentation including Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Commissioning documents, Validation documents (IQ, OQ, PQ, and PV), Functional Requirements and User Requirement Specifications (FRS/URS), technology transfer documents, Operation Project Plans (OPPs), and Validation Master Plans (VMPs)
Supporting a wide variety of processing applications such as CIP/SIP, Depyrogenation, semi-automated vial washing, Formulation, Filling, sterilization (steam, gamma irradiation), labelling, packaging (tyvek tray sealing, foil pouch sealing, and deionization / sealing), centrifugation, lyophilization, automated parts washing, blending, auto-sieving, and milling in both drug and device manufacturing environments
Supporting cGMP utilities such as boilers, process chillers, multi-effect stills, RO/DI pre-treatment, USP Purified Water, pH neutralization, clean steam, filtered compressed air, and WFI systems, located in ISO7/8 clean rooms supporting drug / device manufacturing
Supporting facility related systems, including Elpro Building Monitoring System, Red Cloud Building Security System, and servers / network troubleshooting
Conducting feasibility study to estimate product cost and analyze capital equipment, capacity, and capability requirements
Establishing and improving process methods which meet performance and quality requirements
Leading / assisting in business case development, project team leadership, establishing project budgets and forecasting, 3rd party vendor/contractor management, equipment procurement, Gantt schedule management, project engineering, equipment installation and construction activity support
Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.
Evaluating multiple options to select the most appropriate processes and machining methods, including design, performing engineering calculations, and technical reporting
Execute equipment qualification or process validation project(s).
Expected Areas of Competence
Skilled and knowledgeable in manufacturing and new product processing
Competence with drafting standards and geometric dimensioning and tolerancing
Ability to balance marketing, manufacturing, and design requirements to meet customer requirements
Ability to lead and prioritize multiple medium complexity project assignments and complete work in a timely manner
Good problem solving skills through the use of quality and statistical tools
Ability to effectively work within a cross-functional team to complete critical project tasks
Demonstrates good written and verbal communication skills
Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions
Proficient with Statistical Process Control concepts, process development, CNC programming terminology, and tooling design concepts
Microsoft Office Suite and Project
B.S. in engineering with a minimum of -1-3 years of manufacturing engineering experience. Or other technical or advanced degree plus 5 years of experience in an engineering or technical role.
Knowledge in Lean Principles and or Six Sigma or other problem solving methodology is preferred.
If you are interested in this Manufacturing Engineer job in Braintree, MA , then click "apply" below. Also, feel free to pursue other available opportunities with Modis Engineering by visiting our website at www.modis.com/us. If you have any questions about this opportunity then feel free to contact Felix Avalos at Felix.Avalos@Modis.com