Piper Companies is looking for a Sr. Software Validation Engineer responsible for design-validation-implementation of software applications. This involves Software Development, Validations, Data Management and Technical Support. Ensures the software meets global quality and regulatory requirements for a Manufacturing Company in Exton, PA.
Responsibilities for the Sr. Software Validation Engineer include:
- Manage validation/qualifications for all product manufacturing and quality related software
- Design, create, execute and approve Software Validation protocols for Quality related software – includes full lifecycle focused on the creation of software requirements, hazard analysis and testing
- Perform analysis of software programs
- Communicate cross-functionally with engineering departments and perform ongoing research to assure that all devices are maintained for quality compliance
- Software Development
- Design and develop customized applications for process improvements
- Manage the development of PC software for special applications
- Create software validations lifecycle documents that are included in FDA submissions
Qualifications for the Sr. Software Validation Engineer include:
- BS Degree in Software Engineering, Biomedical Engineering, or Computer Science. In place of degree, 10 years of applicable work experience and professional certifications may be considered.
- Minimum of 7 years Software Development or Software Quality Engineering experience within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry.
- Advanced knowledge of IT systems, preferably in the Engineering environments.
- Experience with managing Virtual Machine systems and basic server administration.
- Experience with any of the following Software Languages: C++, C#, Java, Visual Basic and HTML
Compensation for the Sr. Software Validation Engineer include:
- Salary Range: $80,000 - $105,000
- Full benefits package
Please send resume to Derek Herbine: firstname.lastname@example.org