Software Validation Engineer - IT

flex; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Software Validation Engineer to join their dynamic team. This role involves supporting extraordinary teams in the medical industry by executing software validations and ensuring compliance with regulatory standards. You will leverage your expertise in applied statistics and quality systems to lead projects, train team members, and maintain the highest standards in software validation. If you are passionate about making a difference and thrive in a collaborative environment, this opportunity is perfect for you.

Benefits

Health Insurance

Paid Time Off (PTO)

Qualifications

• 3-7 years experience in medical/life sciences software testing.
• Strong knowledge of regulatory requirements and quality systems.

Responsibilities

• Ensure adherence to software validation processes and review activities.
• Train project team members on achieving quality in deliverables.

Skills

Software Validation

Applied Statistics

Quality Systems

Regulatory Compliance

Problem-Solving

Education

Bachelor's Degree in Engineering or Life Sciences

Tools

CSV (Computer System Validation)

SDLC (Software Development Life Cycle)

Job description

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build, and deliver innovative products that improve the world.

We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives.

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

Job Summary

Summary:

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a/an Software Validation Engineer located in Chennai / Coimbatore.

Reporting to the Senior Manager, the role involves…

What a typical day looks like:

• Good experience in executing medical industry software validations, having led and managed projects.
• Strong working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities including 21 CFR 820, 21 CFR Part 11, ISO 14971, ISO 13485, FDA, EU Medical Device Regulation, GAMP, GPSV, and CSV/CSA.
• High-level strategic problem-solving and reasoning skills. Analyzes, evaluates, and presents information concerning findings, trends with IT in business, and development.
• Ensure adherence to software validation processes and perform review & approval for all the software validation activities.
• Suggests and debates to implement the right SDLC, software validation methods, and procedures with Flex.
• Train and coach project team members on achieving quality in project deliverables (e.g., GDP, V&V Process, CSV, project-related risks management, resolving issues by following the right process, and SOP requirements).
• Conducts meetings (technical & management) to review investigation findings related to IT systems.
• Cooperates with other department personnel and peers in understanding needs and identifying opportunities for improvements.
• Serve as the SME for CSV, maintaining the knowledge and information in the CSV area of expertise.
• Perform software validation activities.
• Liaise between IT, Quality, Project Team, Corporate Quality, and regulatory bodies.
• Keep abreast of regulatory developments and evolving best practices in compliance control.
• Prepare reports for senior management and external regulatory bodies as appropriate.
• Escalate non-compliance issues with resolutions for CSV compliance.
• Support the project team in audit readiness and project audits.
• Expected to travel domestically/internationally as needed.
• Work collaboratively with different departments across geographies.

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

• 3 - 7 years of experience in Medical/Life Sciences industries software testing.
• Strong working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities including 21 CFR 820, 21 CFR Part 11, ISO 14971, ISO 13485, FDA, EU Medical Device Regulation, GAMP, GPSV, and CSV/CSA.
• High-level strategic problem-solving and reasoning skills. Analyzes, evaluates, and presents information concerning findings, trends with IT in business, and development.
• Ensure adherence to software validation processes and perform review & approval for all validation activities.
• Suggests and debates the implementation of appropriate SDLC, validation methods, and procedures.

What you’ll receive for your work:

• Health Insurance
• PTO

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

Flex is an Equal Opportunity Employer. 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, or any other protected status. We provide reasonable accommodations for disabilities. Please email [e-mail] for assistance. Note: this email is only for disability accommodations; applications must be submitted through the proper channels.