17 days old

Validation Scientist

Kelly Services
San Jose, CA 95115
Kelly is hiring a **Validation Scientist** for one of our biotech clients in **San Jose, CA.**

**Location: San Jose, CA**

**Contract Length: 12 months**

**Pay: $50-$55 per hour**

**What will you do?**

+ Participate in all phases of the product development from product definition to final release

+ Responsible for coordinating the efforts of a team of product evaluation test scientists and development scientists and engineers

+ Communicate project status and issues to other functional teams, stakeholders, and management

+ Facilitate in the removal of conflicts and roadblocks as they arise to ensure product evaluation team efficiency

+ Responsible for testing medical device software products and its documentation

+ Evaluation and Acceptance of Requirements as Complete

+ Pass/Failure of Software Test Cases

+ Author project documents and status reports

+ Participate in project planning and progress tracking

+ Contribute to the delivery of the CMD software projects on-time and within budget.

+ Other miscellaneous duties as assigned

**How will you get here?**

+ BS in Chemistry, Biomedical Engineering, Biochemistry or equivalent, MS in Chemistry or related discipline

+ Minimum of 5 years of laboratory experience using software or equivalent experience testing scientific software or experience with Liquid Chromatography/Mass Spectrometry applications.

+ Experience with Medical Device and/or Regulatory device background a plus

+ Familiarity with ISO 13485 & 21 CFR 820 Compliance desirable

**Knowledge, Skills, Abilities**


+ Excellent leadership and communication skills

+ Motivated, Driven, Autonomous work competency

+ Decision making for quality results

+ Provide technical direction and feedback

+ Ability to work in a team

+ A thorough understanding of qualitative and quantitative analytical chemistry

+ Understanding and ability to apply statistical mathematics

+ Demonstrated experience and knowledge of software test methodologies

+ Demonstrated technical\\scientific knowledge in Life Sciences using Mass Spectrometry or similar techniques

+ Familiarity with entire software development process, particularly in an Agile environment

+ Demonstrated experience in using test management tools

+ Experience with defect tracking systems


+ Familiarity with Quality System Regulation and FDA expectations for software and hardware validation is a plus


+ Extensive experience with automation testing and tools

+ Ability to write automation scripts

+ Project Management experience

+ Ph.D. in Chemistry or related sciences


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.


Posted: 2022-09-12 Expires: 2022-10-13

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Validation Scientist

Kelly Services
San Jose, CA 95115

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