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Senior Validation Engineer

4 months ago

Bengaluru, India ValGenesis Full time

ValGenesis is currently seeking a highly motivated Senior Validation Engineer to join our team. As a Senior Validation Engineer, you will be responsible for ensuring that our software products meet the required quality standards and comply with all relevant regulations and guidelines. You will work closely with cross-functional teams to validate software systems, perform risk assessments, and generate validation documentation. 

Responsibilities

  • Hands-on work in an individual capacity leading to deliverables   
  • Diligently work with Product, Engineering, and Testing teams to gain an 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 
  • Ability to manage a team - Allocate work, review work and guide
  • Manage complete validation of products

Requirements

  • Bachelor's degree in Engineering, Computer Science, or a related field.
  • 5+ years of experience in software validation or a related field.
  • Strong knowledge of validation principles, methodologies, and regulations (GAMP, FDA, etc.).
  • Experience in performing risk assessments and generating risk-based validation strategies.
  • Experience in generating validation documentation, such as validation plans, protocols, and reports.
  • Knowledge of software development life cycle (SDLC) and software testing concepts.
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Ability to work independently and collaboratively in a fast-paced, dynamic environment.
  • Attention to detail and a commitment to delivering high-quality work.
  • Ability to mentor and 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.

Today, we continue to push the boundaries of innovation ― enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations.

The Team You’ll Join

  • Our customers’ success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity’s quality of life, and we honor that mission.​
  • We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done.
  • We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward.
  • We’re in it to win it. We’re on a path to becoming the number one intelligent validation platform in the market, and we won’t settle for anything less than being a market leader.​

How We Work

Our Chennai and Bangalore offices are onsite, 5 days per week. We believe that in-person interaction and collaboration fosters creativity, and a sense of community, and is critical to our future success as a company. 

ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by local law.