At Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet.
In the medical and pharmaceutical market, Corbion (formerly known as Purac Biomaterials) is the market leader in the production of resorbable polymers and high-strength, degradable biocomposites for the medical device and pharmaceutical industry. Our resorbable polymers and biocomposites are used to produce orthopedic implants, drug delivery systems, and wound closure applications.
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.
- Hands on design and development of polymer and chemical processes and equipment.
- Design, plan, and implement equipment qualification, equipment validation, product validation, and computerized system validation projects.
- Assist in developing documents, including but not limited to Specifications, protocols, SOPs, batch records and test procedures.
- 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.
- Execute equipment and product qualifications and provide summary reports of findings.
- Lead capital projects with primary responsibility to meet budget and time requirements.
- 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.
- Prior experience with SAP is preferred.
- Demonstrated ability to manage capital projects.
- Working knowledge of HAZOP and process safety reviews, including risk assessments.
- Previous experience reviewing P&IDs for accuracy.
- Experience investigating process deviations and leading Management of Change (MOC), as well as Root Cause Analysis (RCA).
- Demonstrated capability to develop plant and processing improvements.
- Demonstrated experience with equipment software, design and implementation of automation projects at a manufacturing site is preferred.
- Working knowledge of ISO, ASTM, GDP, cGMP, and design controls is highly desirable.
- 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.
- Must be able to work cross functionally on teams involving R&D, Quality, Supply Chain, Production, Sales.
- Ability to read, understand, and follow detailed instructions and record information clearly and accurately.
- Advanced experience with Excel, Word, PowerPoint is required. Experience with MS Project, CAD software, or Rockwell automation software is preferred.
About Corbion
Corbion is the global market leader in lactic acid and its derivatives, and a leading supplier of emulsifiers, functional enzyme blends, minerals, vitamins, and algae ingredients. We use our unique expertise in fermentation and other processes to deliver sustainable solutions for the preservation of food and food production, health, and our planet. For over 100 years, we have been uncompromising in our commitment to safety, quality, innovation and performance. Drawing on our deep application and product knowledge, we work side-by-side with customers to make our cutting-edge technologies work for them. Our solutions help differentiate products in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics. In 2024, Corbion generated annual sales of €1,288.1 million and had a workforce of 2,399 FTE. Corbion is listed on Euronext Amsterdam. For more information: www.corbion.com
Corbion is an equal opportunity employer and committed to a diverse workplace. All applicants will be considered equally without regard to race, color, ethnicity, veteran status, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, handicapping condition, membership in an organization or any other non-merit factors.
Corbion provides reasonable accommodation to applicants.
EOE/M/F/Vet/Disabled
Corbion does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. All candidates must be submitted by approved Corbion vendors who have been expressly requested to make a submission by our Talent Acquisition team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Corbion Talent Acquisition team and such candidate was submitted to the Corbion Talent Acquisition Team.
