Position Details

Type Full-Time

Experience mid

Exp. Years 2+ years

Education Bachelor's degree, preferably in Biology, Chemistry or Engineering

Category Engineering (Non-Software)

About this role

This role involves planning, executing, and reviewing validation activities within a pharmaceutical manufacturing environment, ensuring compliance with regulatory standards and supporting quality systems.

Key Responsibilities

Participate in validation implementation
Review validation documentation
Lead investigations and CAPA
Support regulatory audits
Maintain validated state of equipment and systems

Technical Overview

The position requires knowledge of validation processes, cGMP regulations, validation documentation, and quality systems in a manufacturing setting, with experience in audits and investigations.

Ideal Candidate

The ideal candidate is a mid-level validation engineer with 2+ years of experience in pharmaceutical or biotech manufacturing, familiar with validation processes, cGMP regulations, and quality systems. Strong documentation and regulatory audit support skills are essential.

Must-Have Skills

Planning validation tasksExecuting validation activitiesReviewing validation documentationParticipating in validation implementationSupporting regulatory audits

Nice-to-Have Skills

Experience in ManufacturingQuality or EngineeringKnowledge of quality / compliance managementExperience with APIBulk Drug or Finished goods manufacturing

Tools & Platforms

Validation documentation toolsCAPA systemPlant quality systems

Required Skills

Validation activitiesValidation Master PlanCommissioning documentationInvestigation reviewPlant SOPsPreventive and corrective actionscGMPValidation documentationPlant quality systemsRegulatory audits

Hard Skills

Validation activitiesValidation Master PlanCommissioning documentationInvestigation reviewPlant standard operating proceduresPreventive and corrective actionscGMPValidation documentationPlant quality systemsRegulatory audits

Soft Skills

Verbal communicationWritten communicationProblem solvingAnalytical skillsInterpersonal relationsNegotiation skills

Industry & Role

Industry Healthcare & Medical

Job Function Validation engineering in pharmaceutical manufacturing

Role Subtype Engineering (Non-Software)

Keywords for Your Resume

Validation EngineerValidation activitiesValidation Master PlanCommissioning documentationPlant standard operating procedurescGMPRegulatory auditsCAPA systemValidation documentationManufacturingQualityEngineeringPlant quality systemsValidation failuresPreventive and corrective actionsvalidationvalidation engineervalidation documentationregulatory auditsinvestigation reviewplant quality systemscommissioningpreventive actionscorrective actions

Deal Breakers

Lack of Bachelor's degree in relevant field, No experience in validation or manufacturing, Unfamiliarity with cGMP or regulatory standards

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