Lisbon, Portugal · On-site
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 transform…
Skills: Functional Testing, GxP Regulations, 21 CFR Part 11, EU Annex 11, Validation Protocols
Lisbon, Portugal · Remote OK
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 …
Skills: Project Management, Business Analysis, Software Implementation, Configuration Support, Risk Mitigation
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The role involves planning and executing system testing and integration for enterprise software platforms within an Agile environment. Responsibilities include managing test repositories, ensuring full traceability, and utilizing AI tools for test automation across web and mobile platforms.
Candidates need 2 to 6 years of experience in enterprise software development and strong functional testing skills. Knowledge of pharmaceutical regulatory standards like GxP, 21 CFR Part 11, and GAMP 5 is highly valued.
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.valgenesis.com/about
\nRequirements:2 to 6 years of experience with enterprise software product development lifecycle/phases.
Strong experience in Functional testing of all test phases, including test strategy, test design.
Solid understanding of GxP regulations and 21 CFR Part 11 / EU Annex 11 compliance and familiarity with Validation Protocols (IQ, OQ, PQ) is a plus.
Previous experience working within the Pharmaceutical, Biotech, or Medical Devices industries is highly valued.
Experience using Jira and Test Management tools (e.g., Xray, Zephyr) to manage regulated documentation.
Able to work collaboratively and independently with speed and minimal supervision.
Experience/knowledge in pharma regulatory, quality, risk, process validation software systems (e.g., GAMP 5 framework)
Experience with AI powered automation frameworks like Playwright, TestRigor etc is preferable.
Develop deep expertise in our products and their uses in the pharmaceutical industry.
Plan and execute enterprise software platform integration, system testing activities
Work with software developers and product managers in an Agile team environment.
Create and Manage test repository (scenarios, cases, steps, priorities, categories etc), test metrics, maintaining full traceability between requirements and test cases (Traceability Matrix).
Ability to map data flows in the software as a basis to develop challenging and robust testing.
Conduct QA tests and verify outcomes within schedules/timelines.
Part of a team (BA/PO, Developers, SDETs etc) that develop enterprise software applications.
Understand the business requirements and design, development/coding aspects.
Participate in the complete development life cycle
Use AI tools/capabilities to automate the generation, automation, execution of test suites
Performing test automation on multiple application platforms – Web, Mobile et
Manage/Involve with CI/CD specific activities.
Own and be accountable for the Quality, Reliability and Compliance of the respective product deliverables.
Strive for self-excellence along with enabling success of the team/stakeholders.
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.
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.
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.
The industry standard paperless validation software for biotech, pharma, medical device and other life sciences.
ValGenesis delivers integrated and smart solutions that support the digital transformation of the life sciences industry. With a portfolio that covers the whole product lifecycle, ValGenesis has a digital or technical solution that brings value to each step of your validation and manufacturing processes and their related activities.
Offices: 5201 Great America Parkway, Suite 354, Santa Clara, CA 95054, US · 4211 W Boy Scout Blvd, Suite 160, Tampa, Florida 33607, US · Evert van de Beekstraat, 1-104, CL Schiphol, The Netherlands 1118, NL · C S I R Road, Taramani, 705-708, 7th Floor, Phase II, TICEL BIO Park Limited, Chennai, Tamil Nadu 600113, IN · 2000 Argentina Road, Suite 220, Mississauga, Ontario L5N 1V8, CA
The industry standard paperless validation software for biotech, pharma, medical device and other life sciences.
ValGenesis delivers integrated and smart solutions that support the digital transformation of the life sciences industry. With a portfolio that covers the whole product lifecycle, ValGenesis has a digital or technical solution that brings value to each step of your validation and manufacturing processes and their related activities.
Offices: 5201 Great America Parkway, Suite 354, Santa Clara, CA 95054, US · 4211 W Boy Scout Blvd, Suite 160, Tampa, Florida 33607, US · Evert van de Beekstraat, 1-104, CL Schiphol, The Netherlands 1118, NL · C S I R Road, Taramani, 705-708, 7th Floor, Phase II, TICEL BIO Park Limited, Chennai, Tamil Nadu 600113, IN · 2000 Argentina Road, Suite 220, Mississauga, Ontario L5N 1V8, CA
