Validation Engineer

Valuelabs; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Valuelabs in Hyderabad invites experienced professionals to join our pharmaceutical operations team. You will design, develop, test, and validate manufacturing processes following GAMP and cGMP guidance to ensure compliant production.

Collaborate with cross-functional teams to optimize production, document validation protocols, and troubleshoot equipment and process deviations during MES implementations.

Qualifications

• 7-20 years of experience in pharmaceutical or life sciences with GXP regulations.
• Strong understanding of HP ALM (Manufacturing Execution System).
• Experience with MES implementation projects.

Responsibilities

• Design, develop, test, and validate manufacturing processes following GAMP principles for regulatory compliance.
• Collaborate with cross-functional teams to identify improvements in production operations and implement changes to boost efficiency and quality.
• Develop and maintain documentation of validation protocols, reports, and records per cGMP guidelines.
• Troubleshoot equipment calibration, cleaning validation, sterilization validation, and process deviations.

Skills

GXP regulations

MES knowledge

Regulatory understanding

Tools

HP ALM

Job description

Roles and Responsibilities :

• Design, develop, test, and validate manufacturing processes using GAMP principles to ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams to identify areas for improvement in production operations and implement changes to increase efficiency and quality.
• Develop and maintain documentation of validation protocols, reports, and records according to cGMP guidelines.
• Troubleshoot issues related to equipment calibration, cleaning validation, sterilization validation, and process deviations.

Job Requirements :

• 7-20 years of experience in pharmaceutical or life sciences industry with expertise in GXP (Good X Practices) regulations.
• Strong understanding of HP ALM (Manufacturing Execution System) software application.
• Experience with MES (Manufacturing Execution System) implementation projects.