6 days ago
Full TimeJunior
Loading description...
Skills Gap Analyzer
Compare your skills with the requirements for Sterile mechanical engineer and see what you need to learn
About the company
WELLKNOWN LIMITED
Retail Office Equipment
ResourcesOne is now hiring for one of our Top 5 Pharmaceutical Companies!
Position : Sterile Mechanical Engineer
Location: Obour City, Egypt
We are looking for an experienced Sterile Mechanical Engineer to join the Technical Operations team and play a key role in ensuring the reliability, maintenance, and continuous improvement of mechanical systems and production equipment within the sterile manufacturing area.
The ideal candidate will have strong experience in pharmaceutical manufacturing, sterile production equipment, mechanical maintenance, troubleshooting, and GMP compliance.
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.