About the role

Work Flexibility: Hybrid

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.

Travel Percentage: None

Aplyr's read

Stryker excels in medical technology, attracting professionals passionate about innovation in orthopedics, surgical, and neurotechnology solutions.
Synthesized from recent postings & public sources

What's promising

•Stryker's innovative products lead advancements in orthopedics and neurotechnology.
•Global presence offers diverse career opportunities across multiple regions.
•Strong focus on research and development fosters continuous innovation.

What to watch

•High competition in the medical technology sector may impact market share.
•Regulatory challenges can affect product launch timelines.
•Complex organizational structure may slow decision-making processes.

Why Stryker

•Stryker's commitment to innovation in medical technology sets it apart.
•Diverse product range across orthopedics, surgical, and neurotechnology.
•Strong emphasis on employee development through varied roles and internships.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Stryker

Stryker

stryker.com

View company

Stryker is a global leader in medical technology, offering innovative products and services in orthopedics, medical and surgical, and neurotechnology and spine.