Senior Validation Lead - Pharma & Vaccines

Shantha Biologics Pvt. Ltd.; Hinoba-an; On-site; PHP 800,000 - 1,200,000; Full time

Job summary

Shantha Biologics Private Limited in the Philippines seeks an Executive/Sr. Executive Qualification & Validation Expert to lead qualification and validation activities across facilities and equipment.

Responsibilities include preparing validation SOPs, IQ/OQ/PQ protocols, and executing qualification tasks for HVAC, water systems, gases, sterilizers and temperature-controlled units. The ideal candidate has 4–6 years in vaccines or pharmaceutical validations, strong technical writing, and

Qualifications

• Experience in vaccines/pharmaceutical validations.
• Strong technical writing abilities.
• Familiarity with regulatory guidance documents.
• Background in Human Vaccines or Pharma Injectables preferred.

Responsibilities

• Prepare validation SOPs.
• Prepare IQ/OQ/PQ protocols.
• Execute qualification/validation activities for HVAC, water systems, gases, sterilizers, and temperature-controlled units.
• Perform routine requalification/re-validation.
• Compile data and prepare reports.
• Inventory management of validation consumables.
• Manage validation equipment.
• Support audit readiness and engineering activities.
• Contribute to QMS actions (Deviations, Change Controls & CAPA).
• Support reporting manager in other activities as assigned.

Skills

Execution of qualification/validation

Technical writing

Regulatory guidance familiarity

Vaccine/pharma background preferred

Job description

Shantha Biologics Private Limited in the Philippines seeks an Executive/Sr. Executive Qualification & Validation Expert to lead qualification and validation activities across facilities and equipment.

Responsibilities include preparing validation SOPs, IQ/OQ/PQ protocols, and executing qualification tasks for HVAC, water systems, gases, sterilizers and temperature-controlled units. The ideal candidate has 4–6 years in vaccines or pharmaceutical validations, strong technical writing, and