Principal Validation Engineer

Careernet; Bengaluru; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Careernet is seeking an experienced Validation professional to lead process, system, and equipment qualification activities in a regulated manufacturing environment. You will develop validation strategies, prepare and review protocols and reports, and drive CAPA actions with structured problem-solving methods.

Ideal candidates have 7–12 years of hands-on validation experience, strong documentation skills, and a solid background in cGMP/GxP.

Qualifications

• 7 to 12 years of relevant validation experience in a regulated manufacturing environment.
• Hands-on validation experience across process, system, and equipment environments.
• Strong protocol and documentation capability for regulated manufacturing operations.
• Risk assessment and process optimization experience in a quality-driven setting.
• Ability to support compliance, technical problem solving, and data-based decision making.

Responsibilities

• Lead validation projects and develop validation strategies for process, system, and equipment qualification activities.
• Prepare, review, and maintain validation protocols, reports, and technical documentation in line with regulatory and quality requirements.
• Conduct risk assessments, investigate technical issues, and support CAPA actions using structured problem-solving methods.
• Apply statistical tools such as DOE, SPC, and Cp/Cpk to support process monitoring and improvement initiatives.
• Support compliance with cGMP, SOPs, and GxP requirements while driving continuous improvement in quality and efficiency.

Skills

Validation

Process Validation

System Validation

Equipment Qualification

cGMP

GxP

SOPs

CAPA

Risk Assessment

DOE

SPC

Cp/Cpk

Process Optimization

Quality Compliance

Education

Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related discipline

Job description

Key Skills:

Validation, Process Validation, System Validation, Equipment Qualification, cGMP, GxP, SOPs, CAPA, Risk Assessment, DOE, SPC, Cp/Cpk, Process Optimization, Quality Compliance

Roles & Responsibilities:

• Lead validation projects and develop validation strategies for process, system, and equipment qualification activities.
• Prepare, review, and maintain validation protocols, reports, and technical documentation in line with regulatory and quality requirements.
• Conduct risk assessments, investigate technical issues, and support CAPA actions using structured problem-solving methods.
• Apply statistical tools such as DOE, SPC, and Cp/Cpk to support process monitoring and improvement initiatives.
• Support compliance with cGMP, SOPs, and GxP requirements while driving continuous improvement in quality and efficiency.

Experience:

• 7 to 12 years of relevant validation experience in a regulated manufacturing environment.
• Hands-on validation experience across process, system, and equipment environments.
• Strong protocol and documentation capability for regulated manufacturing operations.
• Risk assessment and process optimization experience in a quality-driven setting.
• Ability to support compliance, technical problem solving, and data-based decision making.

Good to Have:

• Medical device or pharmaceutical manufacturing background.
• Experience with GxP validation practices and GxP compliance.
• Project management exposure in validation or quality programs.
• Experience preparing reports for regulated environments.

Education:

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related discipline.