Sr Software Quality Validation EngineerReq #:
JR - 018812Location:
4/24/2020 3:50:44 PM
Baxter International Are you looking for a career that matters?
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Job Title:Senior Software Quality Validation Engineer
Supervisor's Title:Senior Principal Software Quality Engineer
FLSA: Exempt Position Summary
Applies a solid understanding of theories/practices utilized by software quality engineering toward the validation of new or enhanced computerized systems. Plans, executes and functionally directs important computer system validation assignments, which require independent judgment. Job Responsibilities
Knowledge, Skill and Abilities
- Lead or assist with validation related activities in the development of new or improved computer systems
- Independently work on cross-functional team in detailed phases of the software quality development life cycle to ensure a high-quality product which meets all user requirements.
- Write or assist with all computer system validation documentation, including User Requirements Specifications, Design Specifications, Trace Matrix, Qualification Protocols, Risk Analysis, Test Cases, Test Defects and Testing Summary Reports.
- Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Required Education and Experience
- Must have experience and demonstrate proficiency in the software validation field (e.g. software validation and verification, technical writing, problem analysis and resolution)
- 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 safety and quality instructions, and comprehend written work instructions, including drawings.
- Must have basic English written and oral communication skills to communicate with other team members.
- Strong understanding of current data integrity requirements
- Familiarity with databases e.g. Universal, Oracle and SQL (preferred).
- Familiarity with 21 CFR Part 11 ERES, and GAMP-5
Other Duties as Assigned
- B.S. degree and 2 years of experience in Quality Assurance in software validation environment.
- Demonstrated success in delivering results on concurrent technical challenges.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required. Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Pay Transparency Policy Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail toAmericas_TTA@baxter.comand let us know the nature of your request along with your contact information.