Job Description

At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always.

Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose -- to make great products that create value and improve people's lives.

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we're looking to add Software Validation Engineer - IT located in Chennai Location.

Reporting to the Senior Manager & the role involves

What a typical day looks like:

• Knowledge of software testing in life sciences/Pharmaceutical domain
• Must author and execute the software validation test cases - OQ/PQ
• Have thorough knowledge on Software Test Lifecycle and Defect Management processes
• Good knowledge of cGMP, GAMP, GDP, 21 CFR Part 11 and 21CFR Part 820 guidelines
• Review and modify validation documentation including but not limited to: User Requirements Specifications (URS) / Functional Requirement Specification (FRS)
• Participate and provide inputs for Functional Risk Assessment

The experience we're looking to add to our team:

• Bachelor's in Computer Science or Equivalent is required
• 5-8 years of experience in Pharmaceutical Industry
• Strong technical writing to develop validation protocols
• Excellent communication skills
• Excellent attention to detail, analytical and problem-solving skills
• Experience with IQ, OQ and PQ protocols
• Knowledge of GMPs
• Communicate and collaborate effectively with IT - Business and Quality Teams
• Proactive, self-starter and capable of working alone or in a team environment.

What you'll receive for the great work you provide:

• Health Insurance
• Paid Time Off

NK99

Job Category Quality

Required Skills: Computer Software Validation, Computer System Validation (CSV), Manual Testing, Software Testing Life Cycle (STLC), Software Validation

Optional Skills: Flex pays for all costs associated with the application, interview or offer process, a candidate will not be asked for any payment related to these costs.

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the recruitment process. Please advise us of any accommodations you may need by e-mailing: .