Validation Engineer

Prismtech Packaging Solutions Private Limited; Navi Mumbai; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Prismtech Packaging Solutions Private Limited in Navi Mumbai seeks a Quality Assurance / Validation professional with 5–8 years of experience to lead validation activities across equipment and processes.

You will plan and execute VMP, DQ, IQ, OQ and PQ, manage FAT/SAT, commissioning and qualification, and prepare validation reports while ensuring compliance with cGMP, GAMP 5, FDA/EU GMP and WHO GMP requirements.

Qualifications

• Qualification includes B.E./B.Tech. in Mechanical, Electrical, Instrumentation, Automation, or Pharmaceutical Engineering.
• Pharma validation certification is preferred (M.Pharm/validation).
• Experience in validation documentation and regulatory standards is expected.

Responsibilities

• Plan and execute VMP, DQ, IQ, OQ & PQ activities and validation reports.
• Handle FAT/SAT, commissioning and qualification activities.
• Ensure compliance with cGMP, GAMP 5, FDA, EU GMP & WHO GMP requirements.
• Manage deviations, CAPA, change controls and risk assessments.
• Review drawings, P&IDs, electrical/software documentation and machine specs.
• Coordinate with Design, Production, Automation, Service, Quality and customers.
• Support customer audits, regulatory inspections and customer-site validation.
• Prepare SOPs, protocols, reports and maintain validation documentation.

Education

B.E./B.Tech. in Mechanical, Electrical, Instrumentation, Automation, Pharmaceutical Engineering or equivalent

M.Pharm./validation certification preferred

Tools

MS Office

CAPA

Job description

Department: Quality Assurance / Validation

Experience: 5–8 Years

Key Responsibilities:

• Plan and execute VMP, DQ, IQ, OQ & PQ activities and validation reports.
• Handle FAT/SAT, commissioning and qualification activities.
• Ensure compliance with cGMP, GAMP 5, FDA, EU GMP & WHO GMP requirements.
• Manage deviations, CAPA, change controls and risk assessments.
• Review technical drawings, P&IDs, electrical/software documentation and machine specifications.
• Coordinate with Design, Production, Automation, Service, Quality and customers.
• Support customer audits, regulatory inspections and customer-site validation.
• Prepare SOPs, protocols, reports and maintain validation documentation.

Qualification: B.E./B.Tech. in Mechanical, Electrical, Instrumentation, Automation, Pharmaceutical Engineering or equivalent. M.Pharm./validation certification preferred.

Preferred Experience: Pharmaceutical/packaging machinery, pharma equipment, automation or engineering industry; customer-facing validation experience preferred.

Skills: Validation documentation, DQ/IQ/OQ/PQ, GAMP 5, cGMP, FAT/SAT, CAPA, risk assessment, change control and MS Office.