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Lead Validation Engineer @ ValGenesis

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 Lead Validation Engineer

Job Description

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/watch?v=tASq7Ld0JsQ 

About the Role:


ValGenesis is the market leader in end-to-end digital validation and we are looking for a Lead Validation Engineer to join our team in Chennai. In this role you will drive the validation processes of our cutting-edge products, ensuring they meet the highest quality standards.
Responsibilities
  • Collaborating with Product, Engineering, and Testing teams to gain a comprehensive understanding of product functionalities.
  • Reviewing Product Requirements including Epics, User Stories, and Software Requirements.
  • Developing thorough test cases in Operational Qualification (OQ) and Performance Qualification (PQ) protocols aligned with guidelines.
  • Creating realistic test cases and datasets based on real-world customer scenarios.
  • Executing test cases, logging defects, documenting deviations, and reporting test outcomes.
  • Peer reviewing test documentation to ensure quality and adherence to standards.
  • Working collaboratively in a dynamic team environment with open communication.
  • Understanding and adhering to Quality Management System (QMS) standards.
  • Leading a team of engineers, providing guidance, overseeing workload, and conducting reviews.
  • Managing product validation timelines and ensuring quality deliverables.
  • Requirements
  • Bachelor's or higher degree in Computer Science, Biology, Biomedical Engineering, or a related field.
  • At least 8 years of experience in Computer System Validation and Product Software Validation in a regulated environment.
  • Deep knowledge of the product development life cycle.
  • Understanding of GMP, FDA, and ISO regulations.
  • Proficiency with testing tools and Microsoft Office suite.
  • Self-motivated with a willingness to quickly learn new technologies and products.
  • Excellent interpersonal, writing, communication, and troubleshooting skills.
  • Passionate about testing, validation, and product quality.
  • Able to mentor colleagues and lead small projects efficiently.
  • Were on a Mission
    In 2005, we disrupted the life sciences industry by introducing the worlds 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 Youll 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 humanitys 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.
    Were in it to win it. Were on a path to becoming the number one intelligent validation platform in the market, and we wont settle for anything less than being a market leader.

    How We Work
    Our Chennai, Hyderabad 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.

    Job Classification

    Industry: IT Services & Consulting
    Functional Area / Department: Engineering - Software & QA
    Role Category: Quality Assurance and Testing
    Role: Quality Assurance and Testing - Other
    Employement Type: Full time

    Contact Details:

    Company: ValGenesis
    Location(s): Chennai

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    Keyskills:   pq fda oq iso data validation test cases interpersonal skills gmp microsoft office suite testing tools software validation product development life cycle troubleshooting computer system validation product validation development life cycle communication skills

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    ValGenesis

    ValGenesis for over 10 years, we have been helping Life science companies to bring products to market quickly, safely and efficiently by delivering integrated paperless validation life-cycle management software solutions that provide data integrity, consistency, control and transparency across the o...