GxP CSV Validation Engineer I 6 to 14 Years I Hyderabad I

Capgemini; Hyderabad; On-site; USD 6,822 - 13,644; Full time

Job summary

An innovative firm is seeking a GxP CSV Validation Engineer to ensure digital systems in clinical development meet regulatory standards. This role involves developing and executing validation protocols, conducting risk assessments, and maintaining compliance documentation. You will collaborate with various teams to drive transformation and compliance in a dynamic environment. If you are passionate about quality assurance and regulatory compliance, this is an exciting opportunity to make a significant impact in the field of clinical development.

Qualifications

• Experience in GxP compliance and validation protocols.
• Knowledge of regulatory standards like 21 CFR Part 11.

Responsibilities

• Ensure digital systems comply with GxP and regulatory standards.
• Develop and execute validation protocols and risk assessments.

Skills

GxP Compliance

Validation Protocols (IQ, OQ, PQ)

Risk Assessment

Documentation

Education

Bachelor’s degree in Life Sciences

Master’s degree in Computer Science

Regulatory Affairs Certification

Quality Assurance Certification

Job description

GxP CSV Validation Engineer I 6 to 14 Years I Hyderabad

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities, collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow. Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose.

Job Description

• The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11).
• They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits.
• The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards.
• They perform risk assessments and maintain compliance documentation.

Primary Skills

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field.
• Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous.

Ref. code: 185772

Posted on: 17 Mar 2025

Experience Level: Experienced Professionals

Contract Type: Permanent

Location: Hyderabad, IN

Professional Community: Products & Systems Engineering