Job title : Computer Systems Validation Engineer-12345 Job Description: About This Role: To ensure the quality of our client's software applications and equipment by validating/qualifying to specifications. Provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations. Your Responsibilities Include: Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures. Provide project estimates independently. Review estimates for Engineer I's. Submit specification, protocol and report for approvals and documentation control via a Change Request. Develop comprehensive software validations and/or equipment qualification protocols per the specification. Execute software validation and/or qualification protocols & record results. Document communicate and follow-up on software/equipment issues. Complete project deliverables per project schedule and monitor project schedule and scope changes to assure team can meet delivery requirements. Create documents, links and Change Requests utilizing a Product Data Management system. Provide information on FDA/QSR regulations and internal process validation policy with regards to software validations, equipment installation qualifications, electronic records & signatures. Develop and review comprehensive validation procedures in compliance with FDA. Perform project lead activities on small to large-scale validation/qualification projects. Participate in vendor evaluations. Provide guidance, mentoring and training to Engineer I's & II's. Ensure consistency of work among Engineer I's & II's. Provide peer reviews on specifications, protocols and reports. Influences and defines functional, departmental and divisional policies & procedures through involvement with cross-functional engineering initiatives. Provide leadership role on championing functional best practices. What We're Looking For: Minimum Qualifications: Bachelor's Degree in Engineering Discipline 5-9 years direct experience Experience in Medical Device manufacturing specifically writing compliance documentation In depth knowledge of MS Office tools Must have excellent organization, clear verbal and written skills Experience working in a SDLC-system development lifecycle Hand on skills using navigating equipment user interfaces High level attention to detail and ability to support multiple priorities at once Must be team-oriented with people skills and positive can-do attitude in dealing with many customers, from various departments (Engineering, R&D, Manufacturing, Regulatory, etc.) Preferred Qualifications: Experience working in FDA-regulated industry Experience working with a regulatory body in an audit Performed in a quality role ensuring industry compliance Practical knowledge of 21 CFR Part 11 (electronic records/electronic signature) #ZR Three Point Solutions
...Description Stanford Health Care is seeking a Registered Nurse (RN) Clinic OR - Operating Room for a nursing job in Emeryville, California... ...system of Stanford Medicine. Combining clinical care, research, and education to advance the understanding and practice of...
...Job Description Job Description Pinon Unified School District, a primary/secondary education provider, is seeking a Substitute Custodian to ensure that our facilities are clean, safe and fully operational for the students, staff and visitors. The successful candidate...
...Description Job Description JOB SUMMARY: The position of Sr. Loan Agent is responsible for the processing of a mortgage loan from... ...change on a monthly basis Update all clients files daily Sign borrowers for mortgage loans EXPERIENCE REQUIREMENTS: ~3-5...
...Job Description Job Description For the Fort Payne, AL location : We are seeking Light Industrial to become a part of our team! If you haven't already came by our Fort Payne office to apply in person; click this link to apply with us today: Must have proof...
...Description Grow your career with a leading west Michigan restaurant group, known for our commitment to excellence, creativity,... ...a passionate and experienced Restaurant General Manager / Director of Operations to join our dynamic team and help oversee service and operations...