Req #: 18000A2I_en
Position Summary Applies a solid understanding of theories/practices utilized by software quality engineering toward the development of new or enhanced computerized systems and analytical instrumentation. Plans, executes and functionally directs important software engineering assignments, which require independent judgment.
- Applies state of the art techniques in the area of expertise to develop new or improved computer systems or implementation of analytical instruments.
- Independently work on cross-functional team in detailed phases of the software quality engineering and analytical instrumentation qualification process to ensure a high quality product.
- Develop and execute test cases and identify defects.
- Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Knowledge, Skill and Abilities
- Must have experience or advanced training and demonstrate proficiency in the software engineering field (e.g. software development, software validation and verification, technical writing, problem analysis and resolution) as well as analytical instrumentation qualification/validation.
- Familiarity with 21 CFR Part 11/Data Integrity requirements for computerized systems and analytical intruments.
- Completely proficient in technical writing and Microsoft Office.
- Strong attention to detail to identify defects and usability issues.
- Successful track record of managing wide-ranging activities.
- Extensive cross-functional team experience.
- Ability to organize and present technical overviews without assistance.
- Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
- Must have basic English written and oral communication skills adequate to communicate with other team members.
- Familiarity with Universal Databases and SQL.
Required Education and Experience B.S. degree and minimum of 2+ years of experience in Analytical Instrument Validation/Quality Assurance in software development environment.