Manufacturing Engineer

At Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet.

 

We are hiring a Manufacturing Engineer to support the manufacturing of resorbable polymers in our Tucker, GA Biomaterials plant. As our next Manufacturing Engineer, you will play a key role in ensuring production plans can be achieved consistently with goals for safety, quality, customer satisfaction, sales, overall equipment/building efficiency as well as regulatory compliance (OSHA, FDA, EPA). You will be responsible for supporting existing manufacturing processes and supporting the transfer of new processes which involve melt processing of polymeric biomaterials made according to cGMPs. You will also be responsible for concept development, equipment design and installation, vendor management, and process development, validation, and optimization. One of your primary focuses will be to improve efficiency of operations, install equipment upgrades and capital expansions, support the manufacturing team, and design new installations; all in a cGMP (FDA regulated) environment.

 

Duties and Responsibilities

• Champion the Tucker site's safety culture and participate in its Behavior Based Safety (BBS) journey.
• Contribute as a chemical, mechanical, biomedical polymer, composite processing, and automation subject matter expert at the site.
• Design, plan, and implement equipment qualification, equipment validation, product validation, computerized system validation, and decommissioning projects.
• Assist in developing documents, including but not limited to Specifications, protocols, SOPs, batch records and test procedures.
• Lead review and update of site HAZOPs.
• Lead capital projects with primary responsibility to meet budget and time requirements.
• Hands on design and development of polymer and chemical processes and equipment.
• Work with outside vendors and design development partners.
• Suggest solutions to manufacturing challenges based on experimental data and implement those recommendations working closely with cross-functional partners.
• Develop and protect Corbion intellectual property associated with product or processes.
• Maintain compliance to applicable regulatory requirements and internal quality policies.
• Assist with QRA and/or FMEA implementation and lead process of QRA and/or FMEA and Root Cause Analysis (RCA), as needed.
• Sustain ongoing continuous improvement initiatives related to facilities, equipment and product realization.
• Other duties as assigned 

 

Qualifications

•  3+ years of relevant engineering experience.  Experience with firms supplying materials to medical device makers and pharmaceutical firms, preferred.
• Bachelor Degree in relevant engineering field (Materials Science, Chemical Engineering, Plastics or Polymer Engineering, Biomedical Engineering, Mechanical Engineering). Master's degree in similar field of study is considered a plus
• Proficiency with cGMP requirements under FDA, ICHQ7, ISO 9001 or ISO 13485 environments.
• Working knowledge of ISO, ASTM, GDP, cGMP, and design controls is highly desirable.
• Experience investigating process deviations, leading Management of Change (MOC), Root Cause Analysis (RCA) and equipment commissioning and qualifications.
• Working knowledge of HAZOP and process safety reviews, including risk assessments.
• Previous experience with Rockwell Automation and ability to navigate and understand controls programs is preferred.
• Demonstrated ability to manage capital projects. 
• Prior experience with SAP is preferred.
• Demonstrated capability to develop plant and processing improvements.
• Excellent organizational, written, and verbal communication skills is a requirement.
• Experience using Design of Experiments (DOE) and the implementation of Six Sigma principles to optimize processes is highly desirable.
• Prior experience related to the processing of biomaterials, especially resorbable polymers is a plus.
• Understand OSHA, FDA, and EPA regulatory laws and compliance.
• Hands on experience working with reactors, pumps, tanks, filters, heat exchangers, glass manufacturing, extrusion, etc.
• Previous experience rev