CQV Lead/ Engineer (OSD/Injectables Process Equipment Qualification Hyde Engineering + Consulting

4.0 - 10.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. You will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Additionally, you will review, analyze, and interpret system performance data, handle deviations/discrepancies, conduct investigations, CAPA, and ensure promotion of cGMP and regulatory compliance in assigned projects. Furthermore, you will exercise good judgment in selecting methods and techniques for obtaining solutions, maintain GDP, ALCOA practices, and have hands-on experience with Pharma Process Equipments. Drafting equipment operation SOPs will also be a part of your role. Qualifications & Other Requirements: - BS/MS in Engineering (Chemical, Pharma). - 4-10 years of experience in validation, quality systems, operations, engineering, or a combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Knowledge of Validation Lifecycle approach, international regulatory requirements, and standards. - Experience with Documentum or Maximo is a plus. - Strong verbal and written communication skills, excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products.,

Posted 4 days ago

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PLC Engineer 4P Consulting Inc.

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

As an experienced PLC Engineer with a minimum of five years of desirable experience, you will be responsible for installation, commissioning, troubleshooting, optimization, and validation of aseptic filling and packaging equipment in Food / Beverage plants. Your expertise in Siemens S7 programmable logic controllers, HMI configuration, process validation, and Logic Simulation will be crucial for the successful execution of projects. Furthermore, experience in other PLC systems like Rockwell Automation would be advantageous. Your role will also require a good understanding of different process sensors, instruments, measurements, and servo drives of aseptic filling and packaging equipment, along with proficiency in interfacing with PLC systems. Knowledge of PLC interfacing with other systems such as OPC UA and Modbus, as well as experience in Power / Water projects involving PLC-DCS-SCADA, will be beneficial. You should have a strong grasp of P&ID drawings and the ability to create and modify process graphics. Additionally, you will be expected to possess good knowledge of using test instruments for start-up and commissioning activities, as well as experience in FAT-SAT of PLC-based control systems, loop checking, and documentation of software and hardware. The role will also involve leading a team of technicians for wiring and instrument troubleshooting, necessitating strong team leadership skills. Being a good team player and having experience in working and coordinating with cross-functional engineers will be essential in this role. Your success in this position will be driven by your adherence to strong professional and personal values.,

Posted 1 week ago

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