Technology Compliance Specialist

Molex; Bengaluru; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Molex in Bengaluru seeks a Technology Compliance Specialist to ensure GxP computerized systems are compliant, validated, and inspection-ready across their lifecycle. You will work with Quality, Digital, and business teams to apply risk-based validation practices protecting product quality and data integrity in a global setting.

The role emphasizes CSV, risk assessments, validation documentation, testing execution, and QMS support (Change Control, CAPA, Deviations, Document Management).

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Computer Science, Information Technology, or related field with 8+ years of relevant experience.
• 5-7 years of CSV experience in regulated GxP environments (Pharma, Life Sciences, Medical Devices, or Consulting).
• 5-7 years of risk management experience (FMEA) across the system lifecycle.
• 5-7 years developing and executing CSV test scripts and creating validation deliverables.

Responsibilities

• Define risk-based validation strategies for GxP computerized systems with stakeholders.
• Lead risk assessments including FMEA and data integrity evaluations.
• Develop and maintain validation lifecycle documentation and ensure traceability.
• Design and execute validation testing, assess deviations, and drive resolutions.

Skills

CSV experience

Risk management

Validation testing

Regulatory compliance

Stakeholder collaboration

Education

Bachelor's degree in Life Sciences/Engineering/CS/IT

Tools

Kneat Gx

Veeva

ValGenesis

ALM

Job description

As a Technology Compliance Specialist, you will play a critical role in ensuring that GxP computerized systems remain compliant, validated, and inspection-ready throughout their lifecycle. You will partner with Quality, Business, Digital, and technical stakeholders to apply risk-based validation practices that protect product quality, patient safety, and data integrity while supporting business objectives in a global environment.

Our Team

The Technology Compliance Specialist will join the Molex Cybersecurity team, supporting the validation and compliance of global GxP computerized systems. The team works closely with Business Process Owners, Quality Assurance, Digital Teams, System Owners, and suppliers to maintain compliant, secure, and reliable systems that meet regulatory expectations and support operational excellence.

What You Will Do

• Partner with business, quality, and technical stakeholders to define intended system use and establish risk-based validation strategies for GxP computerized systems.
• Lead and facilitate risk assessments, including FMEA and data integrity evaluations, to identify compliance risks and ensure appropriate validation controls.
• Develop and maintain validation lifecycle documentation, ensuring traceability, technical accuracy, regulatory compliance, and audit readiness.
• Design and execute risk-based validation testing, assess defects and deviations, and drive resolution activities to maintain validated system status.
• Support Quality Management System (QMS) processes including Change Control, CAPA, Deviations, and Document Management while ensuring appropriate CSV oversight.
• Evaluate cloud-based solutions, supplier validation evidence, and software releases to determine compliance impact and validation requirements.
• Collaborate across global functions to maintain inspection-ready systems, support audits, and continuously improve validation effectiveness and compliance processes.

Who You Are (Basic Qualifications)

• Bachelor's degree in Life Sciences, Engineering, Computer Science, Information Technology, or a related discipline with8+ years of relevant professional experience.
• 5-7 years of Computer System Validation (CSV) experience within regulated GxP environments such as Pharmaceutical, Life Sciences, Medical Devices, or Consulting organizations.
• 5-7 years of experience in risk management methodologies, including FMEA, and applying risk-based validation principles across the system lifecycle.
• 5-7 years of experience developing and executing CSV test scripts and creating validation deliverables such as risk assessments, traceability matrices, protocols, and validation reports.
• Strong working knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11, ISO 13485, Data Integrity (ALCOA+), and GxP Quality Management System processes including CAPA, Change Control, Deviations, and Document Management.

Preferred Qualifications

• Experience with Kneat Gx, Veeva, ValGenesis, ALM, or similar validation management platforms.
• Experience applying Computer Software Assurance (CSA) methodologies.
• Experience validating Cloud SaaS/PaaS solutions and performing supplier assessments.
• Experience supporting audits, inspections, software release assessments, and integrated GxP systems.

Work Hours: Expected working hours are 12:00 PM to 9:00 PM IST, with flexibility based on project requirements.

Who We Are

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

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