Computer Systems Validation Engineer

Three Point Solutions

Maple Grove, MN

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)

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Vacancy posted more than 2 months ago

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