Software Validation Facilitator

RESPONSIBILITIES

- Overhauls the company's software validation process.
- Identifies gaps in the procedures and or current validation and mitigates the gaps.
- Handles all software quality assurance activities such as evaluation of software life cycle (SLC) deliverables for compliance with Operating Procedures, FDA requirements and the CFR including 21 CFR Part 11.
- Leads or participates in various reviews, risk analyses and other software quality assurance activities.

SKILLS

Must have a background in software engineering, software life cycle activities, or software validation and be familiar with the work products that result from SLC key activities. Knowledge or experience in requirements gathering, analysis techniques, software verification/validation techniques, configuration management techniques or documentation standards required. The candidate should be familiar with IEEE, SEI, ISO and have experience in a regulated environment. Analytical skills are important, as is the ability to manage tasks. Must be able to manage multiple tasks and resources. Good with verbal and written communication skills. Must have a Bachelor's degree, with a background in software engineering or software quality assurance. Must be a hands-on professional with experience in the software life cycle (SLC).

Synectics is an Equal Opportunity Employer.