Title: Sr. Technician - Calibration
Job Summary:
Sr. Technician responsible for all Maintenance activates related machines breakdowns and preventive maintenance for all Non Sterile plants.
- Responsible to adhere with cGMP principles and maintain them in effective manner and provide engineering support and maintenance activities.
- Ensures that Repair activities are in alignment with company policies and goals and meet or exceed machines maintenance requirements.
- Monitor all safety activities of Engineering Section.
- Responsible to Maintenance Activities for the following Non Sterile Production & Packaging equipment.
Production Equipment:
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- “Fette” Tablet Compression (Fette 2090-I, 2090-II, 3090-I, 3090-II, P1000
- “IMA KILIAN” Tablet Compression (SYN-500, S250 PLUS, T-200/19D)
- “MG2” Capsule Filling (Suprema, Futura)
- “Zanchetta” Granulator (ROTO F600, ROTO P600
- “GEA” Fluid Bed Dryer (T-6 2110)
- “Glatt” Granulator (VG PRO 1200)
- “Glatt” Fluid Bed Dryer (WSG PRO 300)
- “Robert Bosch” Capsule Filling (GKF 2500S, GKF 800
- “Diessel” Sillo Vessel (S01 to S10)
- “Diessel” Holding Tank (HT-01 to HT-11)
- “Diessel” Syrup Manufacturing Vessel (MF-01 to MF-07)
- “Becomix” Manufactring Vessel (LIM 250)
- “Becomix” Premelting Vessel (MV 250)
- “Becomix” Melting Vessel (RW 2000S)
- “Becomix” Homogenizing Mixer (RW 500CD, RW 1000CD, RW 2000CD)
Packaging Equipment:
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- “Uhlmann” Blistering (UPS 1040, B1330, UPS 1020)
- “Uhlmann” Shrink-wrap (ESF 1015, E3025
- “Uhlmann” Cartoner (C-2304, C-2205, C-100
- “CAM” Blistering (NMX, MC)
- “CAM” Cartoner (HV/1, PMX/1
- “Bausch+Strobel” Powder Filling (SPM 4000, SPM 1010)
- “Bausch+Strobel” Filling (UDF 3071,
- “Bausch+Strobel” Capping (RVS 8000,
- “Baush+Strobel” Labeling (ESF1015
- “IWK” Tube Filling (TFS 80-2)
- “IWK” Cartoner (SC5)
- “Norden” Tube Fillling (NM 1700, NML 150-M)
- “Norden” Cartoner (NPS, NPL 150)
- “NIMA” Tube Fillling (MTL200/L DT+JUMBO)
- “Sarong” Suppository (Saas-6, Saas-9)
- Responsible for the overall repair Non sterile Production & Packaging equipment maintenance operations.
- Perform planned preventative maintenance equipment to prevent downtime or reduction in efficiency.
- Responsible for the overhauling and up grading of old machines, if required.
- Ensures that Repair activities are in alignment with company policies and goals and meet or exceed machines maintenance requirements.
- Ensures that the activities carried out in the facility are in compliance with the last CGMP, Workplace Safety and Health and other applicable regulations.
- Develop requirements for capital equipment acquisitions as needed to meet department objectives
- Cost Saving Goals.
- All maintenance and report should be completed on time with no errors.
- Responsible for a smooth running of all Mechanical equipment and fulfilling the requirements of Production/ Packaging Dept. and the Operations.
- Report time and material consumed on job order for requested work.
- Be responsible for preparing for internal and external audits to be ready with required records, data, preventive maintenance documents and SOPs.
- Responsible to assure Good Automated Manufacturing Practice(GAMP), cGMP (Current Good Manufacturing Practice) being adhered and followed
- Ensure the Maintenance of each equipment is carried out as per the Support Recommendation and Instruction manual including Electrical and Mechanical.
- Work on Breakdown by Regular Inspection and Implementation in each related equipment.
- Generate work Completion report, Log Books and Daily Activity Reports.
- Complete Log Books of all Maintenance (Breakdown & Preventive Maintenance) carried out on each equipment for future reference
- Check the daily notifications and Job Orders from the SAP Coordinator.
- Coordinate with SAP Coordinator to complete the all pending notifications from different Users and Preventive Maintenance.
Qualification: Diploma in Mechanical
Experience: At least 5-9 years’ experience in similar organization in Pharmaceutical is preferred, Food
Industries
Requirement:
- Knowledgeable with all types of Non Sterile Equipment, its parts and operation.
- Understands all aspects of pharma machineries installation and maintenance.
- GED (Good Engineering Documents): - Strong knowledge of engineering and maint documents.
- Knowledge of mechanical, electrical, pneumatic, and hydraulic processes.
- Preventive/corrective maintenance: - knowledge of PM/CM planning/scheduling & implementation including planned & unplanned maintenance concept.
- Critical Spare Parts Control: - knowledge of spare parts inventory, ordering and maintaining the min. reorder level.
- Strong command in English (communicating, writing and speaking).v