مهندس ميكانيكا تعقيم

*ResourcesOne is now hiring for one of our Top 5 Pharmaceutical Companies!*

Position : *Sterile Mechanical Engineer*

Location: Obour City, Egypt

*Key Responsibilities* :

* Execute preventive and periodic mechanical maintenance for sterile production equipment according to the annual maintenance plan and defined KPIs.

* Provide immediate technical support and corrective maintenance for mechanical breakdowns to minimize production interruptions.

* Develop preventive maintenance plans and spare parts strategies to maximize equipment reliability and production continuity.

* Participate in mechanical calibration, equipment development, and improvement projects to optimize machine utilization and productivity.

* Prepare Technical Requirement Specifications (TRS) to support URS committees in the selection and procurement of new equipment.

* Identify and implement mechanical safety improvements in line with EHS recommendations.

* Conduct Root Cause Analysis (RCA) and implement effective corrective actions.

* Participate in Deviation Investigations, CAPA, and Change Control activities.

* Monitor and maintain sterile-related mechanical utilities and ensure proper equipment functioning and qualification status.

* Ensure all maintenance activities comply with cGMP, FDA, EU GMP, WHO standards, and approved SOPs.

* Collaborate closely with Production, Quality, Engineering, Utilities, Validation, and EHS teams.

* Manage relationships with suppliers, contractors, service providers, and OEMs to support maintenance operations and continuous improvement.

*Qualifications & Experience:*

* Bachelor’s degree in Mechanical or Mechatronics Engineering.

* 7–10 years of relevant experience in the pharmaceutical industry.

* Strong hands-on experience in mechanical maintenance of pharmaceutical production equipment.

* Experience in sterile manufacturing areas is highly preferred.

* Solid experience with:

* Autoclaves

* Preparation/Holding Tanks

* CIP/SIP Systems

* Ampoule & Vial Filling Lines

* Strong knowledge of cGMP, EHS, and Maintenance Management Systems.

* Strong troubleshooting, problem-solving, decision-making, and RCA skills.

* Excellent communication, teamwork, leadership, and cross-functional collaboration skills.

* Experience in Continuous Improvement / Lean practices is an advantage.