Proclinical is currently recruiting for a Process Engineer for a pharmaceutical company located in Northern Illinois. Successful candidate will lead the operational readiness during new product development and manufacturing changes for a variety of medical device products.
- Process development and optimization through Design of Experiments (DOE).
- Root Cause Investigation utilizing statistical software and process analysis tools such as process mapping, fishbone diagrams, Is/Is not tables, etc.
- Ensure that operations requirements are incorporated into designs during product development.
- Provide leadership to manufacturing locations serving as the communication bridge between the New Product Development (NPD) team and the manufacturing locations.
- Develop advanced manufacturing systems and processes to ensure process capability, repeatability & reproducibility in launched product.
- Drive cross-functional NPD teams to develop and generate PFMEA.
- Participate as a core member of NPD teams and within cross functional NPD team activities such as Design for Manufacturability and Assembly, DFMEA, Design Reviews.
- Lead and coordinate operational readiness and design transfer activities with internal and external manufacturing sites.
- Lead project planning with manufacturing locations to determine manufacturing operational requirements including capacity, space, processes, and capital equipment.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820 (Design Controls), ISO 13485, and other applicable regulatory requirements.
- Knowledge of pharmaceutical process validation and integration with combination products process validation.
- Assist in the improvement and development of new product development processes to enhance development of robust products while reducing time to market.
- Translate internal and external customer needs into equipment and process requirements.
Skills and Requirements:
- BS in Engineer, preferably Mechanical or Industrial Engineering.
- 5+ years of process development engineering experience preferably within medical devices, ideally combination products.
- Strong statistical background (CPK Value, Design of Experiments, Physical Test Methods, TMV, Minitab).
- Proven track record developing and generating PFMEAs.
- Knowledge of standards including FDA 21 CFR 820 (design controls), ISO 13485.
- Experience writing manufacturing procedures and SOPs utilizing lean principals.
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 Tom Bakker at (+1) 312-248-0141 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.
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