عن الوظيفة
As a Mechanical Engineer – Sterile Area, you will be responsible for ensuring the reliable operation, maintenance, and continuous improvement of mechanical systems and production equipment within sterile manufacturing areas, while maintaining compliance with cGMP, safety, and quality standards. The job holder will be based in our Egypt site in El Obour City.Your Responsibilities:Ensure reliable operation and maintenance of sterile manufacturing equipment by:Maintaining and troubleshooting sterile area equipment such as:Filling lines (vials, ampoules)AutoclavesCIP/SIP systemsPackaging LinesAutomatic Inspection M/CsExecuting preventive and corrective maintenance activities.Ensuring minimum downtime and quick response to breakdowns.Ensure compliance with quality and regulatory requirements by:Ensuring all activities comply with cGMP, FDA / EU GMP / WHO standards.Following approved SOPs for maintenance in sterile areas.Participating in deviation investigations, CAPA, and change control activities.Support utilities and sterile support systems by:Monitoring and maintaining sterile-related utilities.Ensuring proper functioning and qualification status.Support equipment qualification and validation activities by:Supporting qualification activities including IQ, OQ, and PQ.Ensuring equipment remains in a validated state.Assisting in requalification and periodic review activities.Drive continuous improvement initiatives by:Identifying opportunities for:Efficiency improvementBreakdown reductionSpare parts optimizationImplementing reliability-centered maintenance (RCM) concepts.Maintain engineering documentation and data integrity by:Maintaining accurate maintenance records (Equipment Log Sheets).Preparing maintenance records, SOPs, and work instructions.Ensuring data integrity compliance.Manage spare parts and inventory activities by:Managing critical spare parts lists.Coordinating with procurement for timely availability.Optimizing stock levels to avoid shortages or overstocking.Ensure compliance with EHS and safety requirements by:Following safety procedures for sterile environments.Ensuring safe maintenance practices in classified areas.Participating in risk assessments (WP & JHA).Collaborate with cross-functional teams by:Coordinating with:Production teamQA/QC departmentsValidation and engineering teamsSupporting internal and external audits and inspections.
EducationBachelor’s degree in Mechanical Engineering.Experience3–7 years of experience in pharmaceutical manufacturing.Experience in sterile/aseptic areas is highly preferred.Technical SkillsKnowledge of:Sterile equipment (fillers, autoclaves, isolators).GMP documentation practices.Familiarity with CMMS systems.Root cause analysis tools (RCA, Fishbone, 5 Why).Soft SkillsStrong problem-solving skills.Attention to detail.Good communication and teamwork.Ability to work under pressure.
