Computer Systems Validation Engineer Job at Three Point Solutions, Osseo, MN

cHBnY1BDQ0N3VExTc1p4TGlDanZyaXB5
  • Three Point Solutions
  • Osseo, MN

Job Description

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

Job Tags

Similar Jobs

Agropur

Packager Job at Agropur

 ...Competitive and comprehensive compensation and benefits package focusing on your physical, financial, and emotional health to include...  ...youll be working: Hull, Iowa Our Hull, Iowa, plant is home to approximately 180 employees. We produce mozzarella, parmesan,... 

County of Los Angeles, CA

RESEARCH ANALYST III, BEHAVIORAL SCIENCES Job at County of Los Angeles, CA

 ...be accepted. DEFINITION : Plans, conducts, interprets and evaluates original research projects involving complex experimental designs in the field of behavioral and social sciences. Essential Job Functions Develops original research hypotheses... 

GLC On-The-Go

Travel Nurse RN - Interventional Radiology - $2,762 per week Job at GLC On-The-Go

 ...GLC On-The-Go is seeking a travel nurse RN Interventional Radiology for a travel nursing job in Plymouth, Massachusetts. Job Description & Requirements ~ Specialty: Interventional Radiology ~ Discipline: RN ~ Start Date: 05/19/2025~ Duration: 13 weeks ~4... 

Semmelmann Interiors

Social Media Manager Job at Semmelmann Interiors

 ...a creative and data-driven Content Marketing Specialist/ Social Media Manager to support our marketing team in driving brand awareness and...  ..., or a related field preferred.~1-2 years of experience in content creation, video production, or digital marketing... 

CertaPro Painters Indianapolis & Dayton

Painting Subcontractor Job at CertaPro Painters Indianapolis & Dayton

 ...documentation is complete and is in compliance with regulations and standards* Maintains positive relationships with customers, subcontractors, suppliers, and other employees* Promotes business development by projecting a positive image of CertaPro during interactions...