Grünenthal Group
Grünenthal Group
Grünenthal Group este o companie farmaceutică bazată pe știință, axată pe gestionarea durerii și a bolilor asociate. Cu sediul în Aachen, Germania, compania dezvoltă medicamente și tehnologii medicale menite să îmbunătățească tratamentul persoanelor care trăiesc cu durere. Operațiunile sale se desfășoară în aproximativ 100 de țări și reunesc circa 4.400 de angajați în echipe de cercetare, dezvoltare, producție și activități comerciale. Fondată în 1946, Grünenthal combină un model farmaceutic integrat cu ambiția pe termen lung de a contribui la crearea unei lumi cu mai puțină durere.

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.

Descriere

  • 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.

Cerințe

  • 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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