Process Validation Engineer

Location: Warsaw, IN Employment Type: Full Time, Employee Expected Duration: 2+ to 5 Years Job Description:Validation and Process engineering in a highly-regulated production environment, in compliance with related codes and standards. Work will involve support of primarily metal machining processes, equipment, materials, and software. Qualification of new equipment, fixtures, and tooling; as well as qualification for procurement, installation, and associated process development for new tooling and equipment. Hands-on support and troubleshooting when needed. Required Skills:REQUIRED: - Four year engineering related degree required from an accredited college or university (NO EXCEPTIONS)- 3+ years of relevant experience in manufacturing environment - Strong documentation skills, and ideally a demonstrated knowledge and proficiency in writing and executing validation plans and protocols (IQ/OQ/PQ or other equivalent terminology from other industries).- Excellent oral and written communication skills and coaching skills are required. This includes an ability to interface effectively with personnel from several departments including floor production workers, machine operators, quality departments, R&D/Product Development, and upper level management. - Strong floor presence DESIRED: - Strong experience working in CNC machining and metal fabrication environments, ideally with exposure to horizontal and vertical mills and lathes. - Experience in medical device or orthopedics is a big plus, or with other highly regulated industries, but is not required - Working knowledge of using Statistical Process Control (SPC), Design of Experiments (DOE), and process capability studies as applicable to validation activities.- Experience working with Stainless Steel, titanium, or other hard metal alloys is strongly desired - Experience with, or knowledge of Unigraphics is a plus, but not required - Experience with, or knowledge of CNC programming is a plus, but not required Contact: PLEASE E-MAIL RESUMES TO: Apply by Email