Installation and Qualification Engineer

Installation and Qualification Engineer

Hovione

Loures, Portugal

You will be responsible to:

• Ensure cGMP and HSE requirements and adequate Engineering solutions are incorporated in the URS and design specifications during the early design phases;
• Contribute to the design review phase of Engineering projects to ensure cGMP and adequate technical solutions are incorporated;
• Execute the construction, assembly, commissioning, and qualification of Engineering projects;
• Create the installation plan and maintain close follow-up for Engineering Projects;
• Guarantee necessary resources, internal and/or external, to meet project plans and deliver expected quality on time and on budget;
• Define and implement technical solutions for unexpected challenges during construction, assembly, and commissioning & qualification of facilities;
• Report and escalate any relevant deviations to plans or objectives promptly and make quality and timely decisions within Engineering tasks;
• Be fully aware of specifications, drawings, work procedures, and ensure contractors receive adequate documentation and training;
• Perform change control assessments as per defined standards and procedures;
• Coordinate commissioning and/or qualification-related activities with involved areas and lead external qualification contractors when applicable.

We are looking to recruit a Candidate:

• University degree, or equivalent qualification, in Engineering (Mechanical, Electrical, Electronics/Automation, or Civil) or a similar scientific field;
• Relevant experience in installation management or equipment qualification and electronic/automation, preferably with a focus on chemical plants or the Pharmaceutical industry;
• Training and experience in GMP and HSE practices;
• Relevant understanding and knowledge of legislation applicable to engineering projects and quality requirements for technical installations;
• Knowledge of equipment (Mechanical, E&I), Quality, cGxPs, ICH, ISPE, and ISO guidelines, and experience in their application;
• Ability to respond to audits;
• Competent in written and verbal English;
• Computer literate with good working knowledge of the MS Office package and CAD software.

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