May, 14th

Projects & Qualification Engineer (Malta)


Role & Responsibilities:

• Manage and coordinate engineering projects related to equipment, systems and utilities;
• Prepare User Requirement Specifications (URS) for new equipment and utilities;
• Perform and document commissioning and qualification activities on manufacturing equipment, plant equipment and utilities in accordance to cGMP guidelines;
• Develop and review commissioning and qualification documentation;
• Analyse qualification test data to determine whether systems or processes have met established criteria or to identify root causes of deviations;
• Identify and design improvements and modifications on current processes and equipment;
• Perform impact/risk assessments and FMEA on processes and equipment;
• Prepare and modify engineering drawings using CAD software.

Qualifications and Experience:

• Degree in Engineering (A warrant to practice as an Engineer in Malta will be considered an asset);
• Project management experience in a manufacturing environment;
• Experience in multiple GMP qualification disciplines (process equipment, utilities, automation and computer systems);
• Knowledge of qualification lifecycle approach (URS, FAT/SAT & IQ/OQ/PQ Protocols);
• Good command of design and visualisation software such as AutoCAD and Inventor;• Knowledge of qualification lifecycle approach (URS, FAT/SAT & IQ/OQ/PQ Protocols);
• Advanced Microsoft Office skills
• Have a minimum of one-year related work experience

 Desired Skills:

  • Ability to work in a logical and organised manner;
  • Ability to take initiative and learn quickly;
  • Excellent troubleshooting skills and possess the ability to analyse problems rationally and provide solutions;
  • Ability to demonstrate excellent people/communication skills;
  • Ability to work unsupervised and on own initiative;
  • Ability to work under pressure, prioritise tasks and meet deadlines

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