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Manufacturing Engineering Manager

Company: gpac
Location: Saint Paul
Posted on: February 23, 2021

Job Description:

A highly respected company in the Life Science industry is looking to bring on a Manufacturing Engineer Manager. This person will provide ongoing commercial process support, improvement, CI initiatives, equipment selection/support, and scientific support and assure compliance with all cGMP, FDA, and DEA standards while mentoring and overseeing a team of 5-6 engineers. The right person will have the ability to review large amounts of data/information, identify trends and draw conclusions. You will need to be a highly motivated individual who can work both independently and as part of a cross-functional team.--Have experience with lean manufacturing and design experience.--Strong technical background with FDA and cGMP knowledge would be helpful. This position offers an excellent compensation and benefits package; apply now!Manufacturing Engineer Manager Responsibilities:* Lead Design Reviews and contribute to activities in the improvement of the commercial mix, coat, slitting, converting, packaging, and serialization processes for drug products.* Assist and troubleshoot process/equipment issues that occur during commercial operations and product changeovers.* Based on QbD principles, plan and execute process studies for feasibility, development/characterization (DOEs), capability, and qualification tied to changes on commercialized processes.* Through CI activities enhance process conditions that increase quality, yield, or reduce set-up and tear-down activities.* Write specifications, R&D Mfg. instructions, protocols, SOPs, process development reports, etc.* Support and follow all regulatory compliance aspects, including following the necessary change control processes.* Lead, research, and write equipment specifications with support from R&D* Lead/support CI activities that increase efficiencies on commercial processes* Support Quality in NCM and CAPA investigations* Maintain accurate and complete records of development activities on commercialized processes.* Support operations with qualification / PM, commercial manufacturing activities, etc.* Interface and provide leadership to project teams, vendors, and clients in all activities from re-development to on-going commercial production.* Provide technical and/or scientific guidance to operations and internal teams when appropriate.* Receive the hand-off of Developed Processes with robust control processes from Validation and R&D* Help with troubleshooting of problems within the manufacturing process* Design/re-design tooling, part and packaging equipment for use in various projects* Other duties as assignedManufacturing Engineer Manager Requirements:* 10+ years of direct industry experience, advanced degrees preferred* 5+ years of hands-on experience in manufacturing process improvement/sustainability within the pharmaceutical industry* Ability to review large amounts of data/information, identify trends, draw conclusions and support a position with text and data* Proven track record of planning and executing process re-development/ CI projects, and an ability to meet aggressive timelines* A highly motivated individual who can work both independently and as part of a cross-functional team* Demonstrated problem-solving and analytical skills* Strong technical writing and oral communication skills. Must be able to effectively communicate results or issues, verbally and in writing* Knowledge and experience with cGMP for pharmaceuticals and QbD principles preferred* Knowledgeable and experienced with cGMP, USP, and the regulatory requirements for pharmaceuticals preferred* Experience in rotary die-cutting and pharmaceutical primary and secondary packaging preferred* Demonstrated experience drafting Manufacturing Records, SOPs, master plans, and additional protocols preferredYou can email me directly at: miki.miller@gogpac.comAll qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 30 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.

Keywords: gpac, St. Paul , Manufacturing Engineering Manager, Engineering , Saint Paul, Minnesota

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