Senior Validation Engineer

About ValGenesis

ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle.Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watchv=tASq7Ld0JsQAbout the Role:ValGenesis is excited to invite applications for the position of Senior Validation Engineer. In this role, you will be pivotal in ensuring the compliance and quality of our innovative software solutions tailored for the life sciences sector. As a Senior Validation Engineer, you will collaborate with diverse teams to develop comprehensive validation strategies, create and execute test cases, and maintain the project quality standard.

Responsibilities

• Hands on work at an individual capacity leading to deliverables
• Diligently work with Product, Engineering and Testing teams to gain understanding of Product functions.
• Review Product Requirements including Epics, User stories, User Requirements, Software Requirements etc.
• Author test cases in OQ and PQ protocols in line with the requirements and QMS guidelines
• Create realistic test cases and test data based on customer usage scenarios.
• Execute test cases, create defects, create deviations, and report test results.
• Peer review Test cases, test data and Test designs
• Work in a highly collaborative team environment, with communication across many team members.
• Good understanding of the company QMS standards
• Author documents in accordance with the QMS guidelines
• Lead of team of people Provide ongoing guidance, allocate work, review work
• Manage the Validation of a product - be responsible for the delivery quality and timelines
  

Requirements

• BE/BS degree or equivalent work experience in Computer Science, Biology,?Biomedical?or related field.?
• Must-have 5+ years of?Computer System Validation and Product Software Validation?testing experience in a regulated environment.
• Good knowledge of Product development life cycle
• Understanding of GMP, FDA and ISO regulations?
• Good knowledge of testing tools and Microsoft office products
• Self-motivated, willing to learn new concepts,?technologies,?and products quickly.?
• Excellent interpersonal, writing and communication skills, and troubleshooting skills.?
• Passionate?about testing, Validation, and product quality
• Able to train and help colleagues with less experience; be able to lead small projects.?
  

We're on a Mission

In 2005, we disrupted the life sciences industry by introducing the world's first digital validation lifecycle management system. ValGenesis VLMS revolutionized compliance-based corporate validation activities and has remained the industry standard.