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Grünenthal Group is a science-led pharmaceutical company focused on pain management and related diseases. Headquartered in Aachen, Germany, the company develops medicines and healthcare technologies designed to improve treatment for people living with pain. Its operations span approximately 100 countries, bringing together around 4,400 employees across research, development, manufacturing, and commercial teams. Founded in 1946, Grünenthal combines an integrated pharmaceutical model with a long-term ambition to help create a world with less pain.
Engineering Manager, GMP Compliance - Grunenthal Group, Quito Onsite
Lead GMP qualification, calibration, validation, and compliance activities for Grunenthal Group’s pharmaceutical manufacturing operations in Quito. Oversee CAPEX projects, investigations, change controls, and critical utility assets.
Description
- Lead commissioning, qualification (IQ/OQ/PQ), and requalification for GMP equipment, systems, and utilities.
- Oversee the calibration master program to maintain metrological traceability and regulatory compliance.
- Ensure adherence to GMP, GEP, ISPE, and validation standards.
- Support CAPEX projects, FAT, SAT, and equipment start-up activities.
- Manage deviation investigations, CAPAs, and change control processes.
- Work across functions to preserve the validated state of critical assets and utilities.
Requirements
- Bachelor’s degree in Mechanical, Electromechanical, Industrial, Chemical Engineering, or a related discipline.
- Five or more years of experience leading qualification, commissioning, calibration, and GMP compliance work.
- Strong understanding of GMP, GEP, ISPE, ASTM E2500, validation, metrology, risk management, and pharmaceutical utilities.
- Experience with HVAC systems, purified water systems, and SAP PM.
- Demonstrated leadership, sound judgment, clear communication, and cross-functional influence.
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