Computer System Validation/Software Testing Engineer (6-8 yrs)

Job Title : Computer System Validation (CSV) / Software Testing Engineer

Location : Pune, India

Experience : 6+ years

Job Description :

We are seeking an experienced Computer System Validation (CSV) / Software Testing Engineer to join our team. The ideal candidate will have a strong background in validating computer systems within regulated environments, ensuring compliance with industry standards and regulations.

Key Responsibilities :

- Develop and execute validation strategies for software systems, ensuring compliance with regulatory requirements (e.g., FDA, GxP).

- Create and maintain validation documentation, including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), and Test Scripts.

- Perform risk assessments and impact analyses on software changes and upgrades.

- Collaborate with cross-functional teams to identify and resolve validation issues.

- Conduct testing, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

- Review and approve software change controls and deviations.

- Ensure compliance with internal quality management systems and industry best practices.

- Provide training and guidance to junior team members on CSV and testing processes.

Qualifications :

- Bachelor's degree in Computer Science, Information Technology, or a related field.

- 6+ years of experience in Computer System Validation and software testing, preferably in a regulated industry (pharmaceutical, biotechnology, or medical devices).

- Strong understanding of software development life cycle (SDLC) and validation life cycle.

- Proficiency in testing methodologies and tools (e.g., Manual Testing, Automated Testing).

- Familiarity with validation tools and techniques, such as GAMP 5 guidelines.

- Excellent problem-solving skills and attention to detail.

- Strong communication and interpersonal skills.

Preferred Skills :

- Certification in Quality Assurance (e.g., CQE, CQA) is a plus.

- Experience with electronic records and electronic signatures (ERES).

- Knowledge of agile methodologies and experience working in agile environments.