Job Openings | USDM Careers



Mechanical Engineer
Engineer
Cleveland, MS

This position is a key role in the filling (of syringes). Primary focus will be on implementing continuous improvement, new business, and capacity expansion projects. Additional focus will also be on manufacturing equipment reliability and process support work.

 

-    Essential Duties and Responsibilities:
-    Complicated part is filling of the syringes
-    Make the solution that goes into the syringe
-    Process starts when mixing solution, fill syringe and package
•             Design/modify precision assembly and/or manufacturing equipment.
•             Manage multiple projects with minimal supervision.
•             Prepare estimates for various tasks and projects.
•             Manage capital projects both directly and through coordinating engineers.
•             Utilize engineering principles to provide mechanical design work for machine components including assembly equipment with robotics, filling machines with servo-drives, mixing equipment, and the control of this equipment.
•             Troubleshoot production problems related to process equipment and develop corrective actions.
•             Research the purchase of new equipment or equipment upgrades to existing process equipment.
•             Develop and test models of alternate designs and processing methods to assess feasibility, operating condition effects, possible new applications, and necessity of modification.
•             Drive Continuous Improvement Activities.
•             Interface with plant and corporate groups as well as contractors and vendors.
•             Manage start-up, debug, and commission of new manufacturing processes.
•             Equipment life cycle management including: upgrades, replacement, and decommissioning
•             Product life cycle management including: product design changes, material changes, Supplier Notice of Change (SNC) assessments, specification changes, etc.
•             Provide technical support/troubleshooting to all plant departments.
•             Resolve operational problems related to projects and minimize delays or unexpected cost increases.
•             Perform process reviews and prepare technical reports detailing equipment operation, best practices and recommended changes.
•             Develop User Requirement Specifications, Technical Specification and Design Specifications for new equipment or upgrades to existing equipment.
•             Author and executes protocols to include FAT, SAT, IQ and OQ.
•             Perform validation maintenance reviews of process and utility systems
•             Suggest and develop energy saving ideas and facility improvements.
•             Prioritize tasks to resolve complex problems.
•             Require little direction, works on technical projects, and has sufficient knowledge within area of functional responsibility.
•             Must have positive attitude, critical thinking and clear decision making skills.
•             Must be able to multi-task, prioritize projects and complete projects on-time within budget.
•             Must be able to read and interpret blueprints, technical drawings, schematics, and computer-generated reports.
•             Research and analyze custom equipment, design proposals, specifications, manuals, and other data to evaluate the feasibility, cost, and maintenance requirements of designs or applications.
•             Estimate costs and submit bids for engineering work including the preparation of capital authorization requests.
•             Demonstrate proactive communication and problem solving.
•             Responsible for supporting and achieving Value Improvement Projects (VIP’s).
•             Responsible for adhering to FDA Design Control standards at all times.
•             Responsible for adhering to and maintaining all department Standard Operating Procedures (SOPs), forms, log books.

Qualifications:
•             Bachelor degree in Engineering Required (Mechanical, Industrial, Electrical, or Computer degrees are preferred)
•             5+ years Engineering / Manufacturing experience. FDA manufacturing preferred.
•             Programming/troubleshooting experience with BMS, HVAC, automated assembly is preferred.
•             Effectively operate in and may facilitate cross-functional teams with guidance.
•             Must be able to provide solutions that reflect understanding business objectives and cost implications.
•             Experience in a pharmaceutical environment writing and reviewing validation and change control documentation
•             Six Sigma Master Black Belt Certification a plus.
•             Project Management skills and experience are a plus.
•             Lean Manufacturing skills and experience are a plus.
•             Must be able to interact with all levels of employees and functions such as quality, validation, manufacturing, purchasing, maintenance, etc.
•             Must be able to meet all cleanroom Personnel Protective Equipment (PPE) for areas of manufacturing where work will be done.



 

Would you like to apply to this job?

Apply Here


Previous MonthNext Month
SunMonTueWedThuFriSat