Validation Engineer Location: Hybrid/Remote: The successful candidate can work on a Hybrid/Remote basis, reporting into one of our offices located in Pennsylvania or North Carolina. Status: Permanent Package: Competitive Salary, Remote/Home Working (with one-off allowance), Flexible Working, (2 Days in the office for our Hybrid workers) Development & Opportunity (Personal & Technical), Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, Long Term & Short-Term Disability Insurance, Generous 401K (matching) Plan, Flexible Spending Account, Health Savings Account, 15 Days' Vacation + Plus Public Holidays + Buy and Sell Scheme. d-wise, an Instem company, designs, deploys, and supports validated cloud infrastructure for life-sciences and clinical trial organizations. Our flagship product, Accel, is a turn-key, validated Statistical Computing Environment (SCE) built on AWS and pre-loaded with SAS, R, Python, and Posit tools; giving biostatisticians and clinical programmers a secure, compliant, and high-performance environment for clinical data analysis and regulatory submission. The Validation Engineer provides validation and compliance services to internal and external clients, ensuring that Instem software and systems meet regulatory requirements and industry standards. The role delivers validation activities across multiple projects, from technical advice, audits and requirements and risk assessments through to test execution. It also plays an active part in shaping how Instem performs validation, championing risk-based approaches and identifying and implementing opportunities to automate validation testing and improve efficiency. Our Culture & Work Environment.
You’ll be part of a friendly, solutions-focused environment within a global business of over 400 people. Here, you’ll experience a high-performance culture balanced with genuine flexibility - we trust you to take ownership, deliver meaningful results, and work in a way that suits you.
You’ll be encouraged to grow, share your ideas, and make a real impact. We’re passionate about creating a place where you can develop your skills, contribute confidently, and succeed in your career.
Why join us as a Validation Engineer? This role is an opportunity for you to shape how we do validation here at Instem, if you are looking for a role where you can shape, define and change processes in validation, this could be a perfect role for you!
What You’ll Be Doing
Validation Activities:
- Validation exercises for internal and external clients: o Planning: Documenting the stages and content of the exercise. o Organizing remote system access. o Assessing risks and advising on mitigation activities. o Execution: Producing documentary evidence that fulfils the planned requirements, including regulatory-acceptable execution of manual and automated tests. o Reporting: Documenting the executed activities, summarizing findings and advising on next steps.
- Detailed fault/deviation analysis and resolution planning.
- Facilitation of Change/Risk Assessment and other validation support activities.
- Support the resourcing and scheduling of validation projects and activities.
- Maintenance of Work Instructions for identified processes and tools.
Validation Approach Definition:
- Help define and evolve Instem’s validation methodology and standards, including risk-based approaches aligned with current industry guidance.
- Identify validation activities suitable for automation, prioritizing by feasibility, effort and expected benefit.
- Design, develop and maintain automated validation tests and frameworks that remain fit for purpose in a GxP context (e.g. tool assurance, evidence capture, data integrity).
- Analyze validation processes and deliverables to remove bottlenecks, duplication and rework, using measures such as cycle time, effort and deviation rates to demonstrate impact.
- Work with Development, QA and Product teams to align validation with the software development lifecycle, leveraging existing development testing where appropriate.
- Pilot new tools and techniques and support their adoption across the team through guidance and training.
Documentation & Reporting:
- Creation of “typical workflow” diagrams or documentation to support requirements analysis.
- Development, maintenance and review of client-facing UAT test scripts.
- Creation and maintenance of Test Evidence packages, including analysis of content extracted from Azure DevOps, automating their production where possible.
- Creation and maintenance of source material and templates in Instem’s Document Management System.
- Review updated Validation Support Package materials for content, coverage, accuracy and formatting against product functionality, system specifications and client requirements.
Client Support:
- Collaborate with internal teams and clients to understand validation requirements and advise on efficient, risk-based approaches, including how automation and Instem’s validation materials can reduce their effort.
- Participate in client meetings and audits as needed.
Compliance & Quality:
- Stay current with regulatory requirements, industry trends and best practice in validation and quality assurance.
- Champion continuous improvement, ensuring changes to validation methods remain compliant and are documented, reviewed and approved.
- Adherence to the Company’s Quality Management System to ensure that all work is handled Securely, Professionally and Diligently.
What We’re Looking For
- Experience in the validation of computer and software systems within a GxP environment
- Knowledge of industry standards such as 21 CFR Part 11, EU GMP Annex 11, GAMP 5, etc…
- Experience with test automation tools (e.g. Selenium, Playwright) and/or scripting (e.g. Python, PowerShell) is a plus
- Familiarity with Azure DevOps or similar application lifecycle management tools
- Demonstrable experience of process improvement, ideally in a regulated environment
- Good knowledge of Microsoft Office products
Ready to Make a Difference?
Join a team that values your perspective and supports your growth, while helping shape the future of life sciences. Apply now - we’d love to hear from you, and our Talent team will be in touch.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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