Sr. Software Validation Engineer; Exton, PA 19341
- Manage validations/qualifications for all product manufacturing and quality related software with other departments to ensure appropriate schedule development and timely follow-up.
- Design, create, execute and approve Software Validation protocols for Quality related software, Engineering tooling and Laboratory equipment – includes full software lifecycle that concentrates on the creation of software requirements, software hazard analysis and software testing.
- Perform analysis of software programs, including security, data storage, and intended use to complete failure investigations and determine the root cause of reported issues. Develop, update, and approve procedures and processes as required to resolve issues.
- Communicate with all engineering departments and perform ongoing research on company tooling to assure that all devices are always maintained in a validated state for 3rd party audit and quality compliance.
- Assist QA management in response to Customer or Regulated Body Audits in all findings related to software quality or security.
- Report any observed software security issues or unacceptable software usage practices to IT.
- Follow Quality System procedures, ISO 9001 and ISO13485, or current regulatory standards.
- Software Development:
- Design and develop customized software applications for Process Improvement and employee requests in Smart-Sheets (Excel, Visual Basic, and Java).
- Manage the development of PC software for special applications. Support COEs by creating software requirements and developing embedded applications using C and VB.
- Create Software Validation lifecycle documents that are included in FDA submissions.
- 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 like Visual Basic or HTML.
- Demonstrated ability to evaluate, develop and implement Software QA processes and procedures.
- Demonstrated ability to manage large scale validation projects.
- Well-developed inter-personal and teamwork skills to communicate and resolve software quality issues with all departments.
- Experience with ISO 9001, or ISO 13485, or MDSAP or 21 CFR 820 a plus.
- $100,000 - $115,000/Year
- Comprehensive benefit package; Medical, Dental, Vision, 401k, and Paid Time Off, bonus eligibility
Please send resume to Eric Bell: email@example.com
validation, engineer, engineering, software
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Software Applications & ERP
Exton, PA 19341