Commissioning & Qualification Engineer

🌟 Title: Engineer, Equipment Commissioning & Qualification

📍 Location: Manati, PR

🛠️ Project Overview

We are seeking a highly skilled Engineer to lead the Commissioning & Qualification Services for the Compressed Air Improvement project. The successful candidate will have a proven track record in commissioning and qualification services, particularly within pharmaceutical manufacturing environments. This role involves leading the validation process to ensure efficient and effective project execution.

🎓 Resource Experience and Expertise Requirements:

• Bachelor’s degree or higher in Engineering, Computer Science, Chemistry, or a related discipline.
• Experience in a pharmaceutical manufacturing environment, especially in packaging.
• Hands-on experience in Commissioning and Qualification.
• Proficiency in Change Control Development using the Infiniti System.
• Strong understanding of cGMP regulations.
• Exceptional documentation skills in English and proficiency with MS Office applications.
• Bilingual in English and Spanish.
• Experience in Computer System Validation.

📋 Duties and Responsibilities:

• Develop comprehensive commissioning and qualification services for compressed air utilities improvements.
• Lead the validation process, coordinating with approvers to ensure adherence to the project schedule.
• Provide timely notifications to the Project Manager regarding any issues that may affect the project timeline.
• Deliver daily progress reports to the Project Manager.

📈 Qualification Activities Scope:

• Develop and secure approval for system requirement specifications.
• Conduct system level impact assessments and component criticality assessments.
• Prepare and approve risk assessments.
• Create and finalize qualification plans and protocols.
• Perform qualification testing and generate necessary protocols and reports.
• Update database with new assets and preventive maintenance services.

If you meet the qualifications and are eager to contribute to this exciting project, we encourage you to apply through the link in this job post!

We look forward to hearing from you! 🌟