Proclinical is currently recruiting for a Manufacturing Engineer with an industry leading pharmaceutical company located in Memphis, TN. Successful candidate will implement continuous improvement, new business, and capacity expansion projects. Additional focus will also be on manufacturing equipment reliability and process support work within the Injection Molding and Devices Operations.
- Upgrade obsolete hardware on existing automated assembly machines (new pressure decay testers, ultrasonic welders, molded part vibratory feeders).
- Design/install/commission multiple new automated device assembly machines into existing cleanroom space.
- Modify existing cleanroom space to match requirements for the new equipment footprint and desired process flow.
- Install/commission new molds and mold machines into existing cleanroom space for new molded components.
- Relocate some existing mold machines to optimize cleanroom space and make room for new mold machines.
- Validate/Qualify activities for new molds, machines, assembly equipment, and cleanroom modifications.
- Assist Project Manager with required project planning, project controls, and procurement work.
- Utilize engineering principles to design/modify precision assembly and/or manufacturing equipment.
- Provide technical support/troubleshooting to all plant departments.
- Demonstrate proactive communication and problem solving.
- Responsible for supporting and achieving Value Improvement Projects (VIP's).
- Responsible for adhering to FDA Design Control standards always.
- Responsible for adhering to and maintaining all department Standard Operating Procedures (SOPs), forms, logbooks.
- Perform process reviews and prepare technical reports detailing equipment operation and preventative maintenance.
- Develop User Requirement Specifications, Technical Specifications, and Design Specifications for new equipment or upgrades to existing equipment.
- Author and executes protocols to include FAT, SAT, IQ, OQ and PQ.
Skills and Requirements:
- Bachelor's degree in Engineering required, (Mechanical, Industrial, Electrical, or Computer degrees are preferred.)
- 7+ years Engineering/Manufacturing experience required. FDA manufacturing experience is preferred.
- Programming/troubleshooting experience with automation controls, automated assembly, control systems, PLC's, HMI's, servo's, and vision inspection systems is preferred.
- Programming/troubleshooting experience with BMS, HVAC, automated assembly is preferred.
- Design software experience (like AutoCAD, Solid Works, etc.) is preferred.
- Six Sigma Master Black Belt Certification or industry standard equivalent is preferred.
- Plastic injection molding experience is a plus.
- Project Management skills and experience (including Microsoft Project software) are a plus.
- Must be able to read and interpret blueprints, technical drawings, schematics, and computer-generated reports.
- Must be able to meet all cleanroom garbing & personnel protective equipment (PPE) requirements for areas of manufacturing where work needs to be done.
- Lean Manufacturing skills and experience are a plus.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Max Kelly at (+1) 312-270-1613 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.