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Drug product operations process engineer

Loures
Hovione
Anunciada dia 5 maio
Descrição

ResponsibilitiesConduct Impact Assessments and Risk Assessments for new or modified systems; Draft User Requirements Specifications (URS) to support project and compliance needs; Contribute to Enhanced Design Reviews, ensuring alignment with technical and regulatory standards; Develop and execute Design Qualification (DQ) protocols; Lead the execution of Commissioning activities and protocols; Generate and carry out Installation Qualification (IQ) protocols; Implement Operational Qualification (OQ) protocols in line with project requirements; Perform Performance Qualification (PQ) protocols to verify process capability; Support the commissioning and qualification of equipment, utilities, and systems (e.g., HVAC, production equipment, formulation equipment, pharmaceutical water systems, nitrogen, clean compressed air, QC equipment); Collaborate with cross‐functional teams to ensure smooth and compliant project execution throughout the equipment lifecycle. QualificationsBachelor's degree or higher in engineering or a related field; Experience in commissioning, qualification, and validation in the pharmaceutical or life sciences industries in valued; Knowledge of industry regulations and standards (e.g. FDA, PIC/S, EMA, GAMP 5, ISPE); Project Management, strong analytical and problem-solving skills; Excellent written and verbal communication skills; Ability to work effectively in cross‐functional teams; Attention to detail and strong organizational skills; Experience with facilities, utilities, systems, and equipment qualification is a must; Experience with computerized systems validation is a plus; Passion for on-field work. Hovione is a proud Equal Opportunity EmployerInclusion and diversity are key to us. We are committed to creating an inclusive recruitment experience and welcome applications from all qualified candidates. If you require any reasonable accommodation or support during the application or interview process, please contact us, and we will be happy to assist.#J-18808-Ljbffr

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