Computer Systems Validation Engineer Job at Three Point Solutions, Maple Grove, MN

Ny80VmZQeTlzdE5JQ2dDWTJTaU5zSDFGOVE9PQ==
  • Three Point Solutions
  • Maple Grove, 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

Job Tags

Similar Jobs

Fiserv

Inventory Control Job at Fiserv

 ...Calling all innovators - find your future at Fiserv. We're Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We connect financial institutions, corporations, merchants and consumers to one another millions... 

Globe Life American Income Division: Sparby Organization

Financial Solutions Associate Job at Globe Life American Income Division: Sparby Organization

 ...Future. Sick of making minimum wage for max effort? Tired of internships that dont pay but look good on a rsum? Its time to...  ...earnings!) Leadership opportunities (no seniority politics) Experience that actually impresses future employersor helps you become... 

CyberCoders

Systems Engineer Job at CyberCoders

 ...Job Description Job Description Systems Engineer Systems Integration Engineer Position Overview We are seeking a Systems Integration...  ...system integration. Qualifications Bachelor's degree in Computer Science, Information Technology, or a related field. Proven... 

New River Community College

Prospect Researcher (Research Technician I) Job at New River Community College

 ...contributions to the University by working together with the campus community. We seek an exceptional individual to join our team as the Prospect Researcher (Research Technician I). The ideal candidate in this role should have a positive attitude and an active, energetic mind... 

PeopleReady

Package Handler Job at PeopleReady

**Package Handler**PeopleReady of Hartford, CT is now hiring Package Handlers in East Hartford, CT!Apply today and you could start as...  ...repeatedly+ Stand and remain active for the entire shift+ Work in a fast-paced environment, moving quickly and safely to meet operational...