Engineering and operations Manager/Insulin API manufacturing
julphar
Total years of experience :21 years, 3 Months
-Overall department planning and manpower planning
-Insulin API plant layout design, equipment layout design, process scale-up, identifying process and equipment requirements, PIDs (process instrumentation diagrams) generation and review, capacity design, occupancy planning, development of USRs (user specification requirements) for production and utility equipment and piping/instrumentation, procurement of equipment, FATs (factory acceptance test), installation and rigging of 95 large scale machines, IQ, OQ and PQ, preparing the plant for validation and commercial production.
-Manage all operation activities for all engineering and operations functions.
-Plan and manage the installation, testing, operation, maintenance, and repair of facilities and equipment (examples of machine: Fermentation systems, large scale high speed centrifuges, homogenizers, TFF systems, HPLC systems, LPLC systems, Freeze dryers, autoclaves, ovens, process vessels, nitrogen system, tank farm, SS piping, instrumentation and others)
-Insulin cartridge (insulin pen) project manager: plant and equipment layout design, identifying process and equipment requirements, capacity design, development of USRs (user specification requirements), procurement of equipment, FATs (factory acceptance test), installation and rigging of machines, IQ, OQ and PQ, preparing the plant for validation and commercial production.
-Insulin cartridge project: Plan and manage the installation, testing, operation, maintenance, and repair of facilities and equipment (examples of machine: insulin cartridge washing machine, cartridge sterilization tunnel, filling machine, pen assembly and labeling machine, autoclaves, insulin tanks, SS piping, instrumentation and others)
-Designing and redesigning of business operations to ensure the efficiency and effectiveness of business operations.
-Lead the Engineering team for the preparation of proper operating and preventive maintenance documentation including SOPs, forms and checklists.
-Manage, review, and approve process/equipment design and changes.
-Lead the Engineering team in performing preventative and breakdown maintenance for all production equipment.
-Managing SIEMENS automation system activities to insure:
*Proper operation and maintenance of the validated process control systems.
*Backup/restore of software.
*Archive/retrieve of electronic data
*Repair activities of servers, clients and automation stations
*Software modification, recipe creation/modification and route control modification.
*Control system licenses Management.
*Assure Good automated manufacturing practice (GAMP), cGMP(current good manufacturing practices) being implemented and Followed.
-Guarantee the implantation of preventive maintenance master plans.
-Guarantee the compliance with GMP, CGMP and GAMP5 requirements.
-Recruit employees; assign, direct, and evaluate their work; and oversee the development and maintenance of staff competence.
-Design, selection, Installation and operation of all the machines and systems in the three production lines (example of machines are: vials washing machines, vials sterilization tunnel, insulin sterile vials filling machines, different labeling and printing machines, steam autoclaves, water superheated autoclaves, preparation vessels ranging from 200 to 6000 liters, and other different types of filing machines designed to fill Intravenous bags and Heamodialysis containers).
-Qualification and validation of all the production machines and systems.
-Generation of all the standard operating procedures (SOPs) related to all the machines.
-Generation of all the Manufacturing and packaging orders.
-Preparing all the facilities for commercial production by: specifying machine spare parts required, consumables required from local and external vendors, capacity planning, staff requirements, etc.
-Launching the commercial production for the three lines after getting local and international site/product approvals.
-Hiring, training and qualification of production staffs.
-Planning and achieving a dramatic increase in the production capacity of all the production units.
-Supervising and managing the production in the three production lines (number of employees under supervision: 53).
I. Non-Sterile manufacturing:
-Operating of various types of equipment such as: reactors, distillation vessels, steam dryers, concentrators, filtration systems, jet mill powder micronizer, etc.
-Operating of production utilities: water treatment units, heating/cooling systems, compressed nitrogen generators, chillers, vacuum units, scrubbing systems, cooling towers, etc.
-Generation of SOPs (standard operating procedures) related to machine operating procedures, cleaning procedures and many others.
-Generation of Manufacturing orders for the different products.
-Qualification of machines and systems by generation of proper IQ/OQ and PQ protocols.
-Preparing the plant for FDA auditing.
-Redesigning old systems which resulted in cutting of major costs.
II. Sterile manufacturing:
-Filling of sterile API products.
-Performing of proper gowning procedures, aseptic behavior inside clean rooms and environmental monitoring.
-Handling of manual, semiautomatic, and fully automated system designed for filling of sterile products.
-Performing of integrity testing for sterile filters in different techniques using up-to-date testing equipments.
-Qualification and validation of machines and systems.
- Micronization of sterile powders using jet mill sterile powder micronizer.
- Installation and operation of different machines used in the sterile areas.
-Generation of SOPs for sterile production related to machine operating procedures, cleaning procedure, sanitization procedures, gowning procedures and many other procedures related to sterile production.
M.Sc. in Business Administration, MBA (average : 90.0 (Excellence), first on the rank), Al Zaytoonah University, 2006-2009, Amman, Jordan. -Master degree thesis title: "Relationship between management readiness for change and employees resistance: field study in the Jordanian pharmaceutical companies".
B.Sc. in Chemical Engineering (average: 80.4, Very Good), Jordan University of Science and Technology, 1998-2003, Irbid, Jordan. -Third on the rank (# of students: 65). -Received two scholarships for the distinguished students (highest average of the year).