Job Summary:
The Software Testing & Computer System Validation (CSV) Engineer is responsible for manual testing of software products and tools required at developmental and verification stages along with ensuring computerized systems used in regulated environments (e.g., GMP, GCP, GLP) are validated in compliance with applicable regulatory requirements such as 21 CFR Part 11, Annex 11, GAMP 5.
What you will do
- Design, develop, and maintain detailed test cases, checklists, and test data; Execute test cases for web, mobile, and desktop applications; Identify, document, and track defects using a bug-tracking tool (e.g., Jira).
- Perform different types of testing: Functional, Regression, Integration, System, Sanity, etc; Participate in review meetings, sprint planning, and daily stand-ups
- Develop and execute validation strategies and plans for new and existing computerized systems.
- Create and maintain validation documents including: User Requirements Specifications (URS); Functional Specifications (FS); Risk Assessment; Validation Plans (VP) ; IQ/OQ/PQ Protocols and Reports; Traceability Matrix.
- Perform impact assessments and change control activities for validated systems.
- Provide training and guidance on CSV processes and best practices.
- Maintain validation documentation in alignment with company procedures and regulatory expectation
What you will need:
Required:
- Experience- 1yrs to 3 years of experience in manual software testing and computer system validation within regulated industries (pharma, biotech, medical devices).
- Bachelor’s degree in engineering, Computer Science, Life Sciences, or related field.
- Good understanding of SDLC, and defect life cycle; Experience with bug-tracking/project management tools (e.g., Jira, Devops); and validating systems such as Valgenesis, and custom applications.
Preferred :
- Understanding of software development life cycle (SDLC) and risk-based validation approaches; CSV certifications (e.g., ISPE, PDA) or GxP training; ISTQB Certification
- Experience in data integrity assessments and remediation projects; Familiarity with cloud-based systems and cybersecurity considerations.
- Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11.
- Excellent documentation, reporting, communication, and project management skills.
Skills Required
- 1 to 3 years manual software testing and computer system validation in regulated industries (pharma, biotech, medical devices)
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field
- Experience designing, developing, and executing test cases for web, mobile, and desktop applications
- Understanding of SDLC and defect life cycle
- Experience with bug-tracking/project management tools (e.g., Jira, Devops)
- Experience validating computerized systems such as Valgenesis and custom applications
- Developing and maintaining validation documents (URS, FS, Risk Assessment, Validation Plans, IQ/OQ/PQ, Traceability Matrix)
- Familiarity with GAMP 5, 21 CFR Part 11, Annex 11 (preferred)
- CSV certifications (ISPE, PDA), ISTQB, or GxP training (preferred)
- Experience in data integrity assessments and remediation; familiarity with cloud security considerations (preferred)
- Strong documentation, reporting, communication, and project management skills (preferred)
Stryker Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Stryker and has not been reviewed or approved by Stryker.
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Healthcare Strength — Healthcare coverage is described as comprehensive, with multiple medical plan options and added protections such as critical illness, accident, and hospital indemnity, plus mental health resources. Wellbeing programs, onsite gyms, and fitness/nutrition classes further reinforce the perceived strength of health benefits.
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Retirement Support — Retirement offerings are seen as strong, highlighted by a competitive 401(k) plan with company matching and potential discretionary contributions. These elements are often viewed as valuable pillars of total rewards.
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Strong & Reliable Incentives — Variable pay is viewed positively, with annual bonuses and sales commissions often lifting total compensation. Incentive plans are seen as a meaningful contributor to pay satisfaction in roles where performance drives earnings.
Stryker Insights
What We Do
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com. Together with our customers, we are driven to make healthcare better.
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