Engineer II Software Validation

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer II, Software Validation who will be responsible for supporting software validation activities at our Ave Maria location. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities: 

• Ensure appropriate regulations, such as 21 CFR Part 11, 820 and cGMP regulations, are addressed in validation. 
• Coordinate, assist and document validation activities; preparation/approval of protocols and reports.  
• Draft, review and approve local validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation. Examples include SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.  
• Perform revalidation and change control validation related activities. 
• Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change. 
• Provide training to colleagues and contractors on our approach to systems implementation and validation SOP’s. 
• Assist validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering, business owners. 
• Develop and maintain Software Validation SOPs, forms, documentation and files. 

Education and Experience: 

• Bachelor’s degree in computer science, technology or related field required 
• 3 years experience in the validation of computer systems, manufacturing, packaging, equipment and process, as well as utilities, and facilities qualification required. 

• Experience in thorough testing of applications, computerized systems, changes and implementations. 

Knowledge and Skill Requirements/Specialized Courses and/or Training: 

• Ability to apply complex system validation principles to work assignments. 
• Must have thorough understanding of FDA regulations and computer validation guidance documents 

• Must be able to function independently, play a leadership role within a cross-functional team and address a variety of moderate to complex problems. 
• Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC), CAPA. 
• Computer knowledge of 21 CFR Part 11, CFR 820 
• Excellent communication skills and customer service orientation 

• Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. 
• Mathematical Skills: Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.   

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.