Qualification & GEP Manager

Grünenthal Group

. Lead commissioning, qualification (IQ/OQ/PQ), and requalification activities for GMP equipment, systems, and utilities.

Posted 10/6/2026full-timeQuito • EcuadorMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading commissioning, qualification, and calibration activities for GMP equipment and systems, ensuring compliance with regulatory standards. Proven ability to manage cross-functional collaboration and drive compliance with validation and metrology requirements.

Highest-signal resume keywords

GMP ComplianceQualification ActivitiesCalibration ManagementLeadership SkillsCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CommissioningQualificationCalibrationValidationMetrologyRisk ManagementGMP KnowledgeGEP KnowledgeISPE StandardsASTM E2500

Soft Skills

LeadershipDecision-MakingCommunicationCross-Functional Influence

Tools & Technologies

SAP PMHVAC SystemsPurified Water Systems

Industry Keywords

GMPGEPValidation RequirementsDeviation InvestigationsCAPAChange ControlCAPEX ProjectsFATSAT

About the role

Key responsibilities & impact

Lead commissioning, qualification (IQ/OQ/PQ), and requalification activities for GMP equipment, systems, and utilities.
Manage the calibration master program to ensure metrological traceability and regulatory compliance.
Drive compliance with GMP, GEP, ISPE, and validation requirements.
Participate in CAPEX projects, FAT, SAT, and equipment start-up activities.
Lead deviation investigations, CAPAs, and change control processes.
Collaborate cross-functionally to maintain the validated state of critical assets and utilities.

Requirements

What you’ll need

A degree in Mechanical, Electromechanical, Industrial, Chemical Engineering, or a related field.
At least 5 years of experience leading qualification, commissioning, calibration, and GMP compliance activities.
Strong knowledge of GMP, GEP, ISPE, ASTM E2500, validation, metrology, risk management, and pharmaceutical utilities.
Experience working with HVAC systems, purified water systems, and SAP PM.
Proven leadership, decision-making, communication, and cross-functional influence skills.