This position shall perform commissioning and qualification of pharmaceutical equipment, including any or all of systems for Oral Solid Dosage, Equipment’s like RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Responsibilities Develop CQMP, VMP, FRA, cGMP review sheet, interdependence Develop System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol. Develop process validation and cleaning validation protocol Execute Commissioning, qualification and validation activities for Pharma Process Equipment’s for OSD. Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data. handling of deviation/ discrepancy, Investigation , CAPA . Promote cGMP and regulatory compliance into assigned projects. Exercise GDP, ALCOA, practice while execution. Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Hands on Experience with Pharma Process Equipment’s. Drafting of equipment operation SOP’s Qualifications & Other Requirements BS/MS in Engineering (Chemical, Pharma). 4-10 years in validation, quality systems, operations, engineering or any combination thereof. Experience in multiple GMP validation disciplines with advanced technical knowledge. Validation experience using, traditional, risk based, Hybrid approach. Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning IQ, OQ, & PQ Protocols, etc.) guidelines, international regulatory requirements and standards. Experience working with Documentum or Maximo a plus. Experience interacting with or creating material for representatives of regulatory agencies and executive level staff. Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions. 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 Valid International passport without any legal obligations in terms of obtaining visa and should be willing to travel Show more Show less

Position: Automation & CSV Engineer Responsibilities 5+ years of experience in a Computer Systems Validation role in a Pharma, biopharmaceutical manufacturing environment. Facilities, Utilities, and Equipment (FUE) qualification Unit operations automation qualification with Honeywell, Delta V, and PLC-based systems Computerized systems validation Support to change controls, investigations, deviations, and CAPAs Technical understanding and experience of automation platforms, such as DeltaV, Emerson, Honeywell, Rockwell PLC, Siemens XFP Ability to effectively lead validation projects, coordinate contractors, junior level personnel and drive results Working closely with the systems integrators, automation leads & process leads Completing the FAT, SAT's, IQ, OQ. creating and executing the protocols & documentation Knowledge of E2500,V Model concepts along with GAMP5, S88,S95 Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments Must be able to solve routine problems with assistance. Strong organizational skills, excellent writing and communications skills Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus Ability to travel up to 50% or more within and outside India Knowledge of Delta-V DCS systems, Rockwell qualification Knowledge of PI Historian. Large scale project experience. Valid Passport with no restrictions to travel any geography Education Engineering degree in Chemical, Automation, Biotechnology, EEE.

Position: CQV Engineer — EMS and BMS Room Location: India This position shall perform commissioning and qualification of EMS and BMS Systems in Pharma/Biopharma Facilities. Responsibilities Develop URS, risk assessment, system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems. Develop and execute Commissioning and validation of EMS and BMS Systems Preparation of System Boundaries, SLIA, CLIA, QRA, Design Qualification Report, Traceability Matrix ,Facility Risk Assessments Develop Protocols and Execute test plans for BMS and EMS Systems. Perform IO Testing ,Control Logics Verification of DDC/PLC and SCADA /Software Testing. Software Verification – SCADA GUI, Reports, Control Access and Security Policies, Power Failure and Communication Failure, Audit Trail Verification, Alarms and Interlocks, Data Backup and Restoration, Control Logics. Perform walkdowns with wiring diagram, P&ID’s and System Architecture ,Air Flow drawings. Knowledge on the system architectures of BMS and EMS . Knowledge on Control logics for T RH, DP, Air flow and Fire Damper ,Smoke and other interlocks in BMS System. Good knowledge of field instruments and devices and their functionality like Temperature and RH transmitters, Level transmitters, Flow meters, Velocity Sensors, control valves, Differential pressure transmitters, Smoke Sensors etc. Verify the instruments calibration reports. Hands on experience in commissioning of other ELV Systems such as Door Interlocks, Access controls ,Fire Alarm Systems etc. Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data. Investigate deviations, write investigation reports and propose corrective and preventive actions and create summary reports. Promote cGMP and regulatory compliance into assigned projects. Knowledge of GAMP ,EU Annexure 11 and US FDA 21 CFR 11 Guidelines . Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Qualifications & Other Requirements BS/MS in Electronics and Communications Engineering. 4-10 years in validation, engineering ,quality systems, operations, or any combination thereof. Experience in multiple GMP validation disciplines with advanced technical knowledge. Validation experience using , traditional, risk based, Hybrid approach. Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning IQ,OQ,& PQ Protocols, etc.) guidelines, international regulatory requirements and standards and other in. Experience working with Documentum or Maximo a plus. Experience interacting with or creating material for representatives of regulatory agencies and executive level staff. Experience with investigations into deviations and determination of product impact potential, root cause and corrective actions. 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. Strong computer knowledge including Microsoft Office products Valid International passport without any legal obligations in terms of obtaining visa and should be willing to travel

This position shall perform commissioning and qualification of Pharmaceutical equipment, including any or all of systems for Oral Solid Dosage, Injectables, Fill/Finish. Equipment’s like 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 Responsibilities Develop CQMP, VMP, FRA, cGMP review sheet, interdependencies Develop System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol. Develop process validation and cleaning validation protocol Execute Commissioning, qualification and validation activities for Pharma Process Equipment’s for API, Fill/Finish and OSD. Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data. handling of deviation/ discrepancy, Investigation , CAPA . Promote cGMP and regulatory compliance into assigned projects. Exercise GDP, ALCOA, practice while execution. Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Hands on Experience with Pharma Process Equipments. Drafting of equipment operation SOP’s Qualifications & Other Requirements BS/MS in Engineering (Chemical, Pharma). 4-10 years in validation, quality systems, operations, engineering or any combination thereof. Experience in multiple GMP validation disciplines with advanced technical knowledge. Validation experience using , traditional, risk based, Hybrid approach. Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning IQ, OQ, & PQ Protocols, etc.) guidelines, international regulatory requirements and standards. Experience working with Documentum or Maximo a plus. Experience interacting with or creating material for representatives of regulatory agencies and executive level staff. Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions. 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

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.,

Position: CSV/Automation Engineer Responsibilities 5 to 10 years of experience in multinational pharma/biopharma companies with hands on experience in Process automation engineering Experience in designing and implementation/testing/commissioning/Qualification of (DCS/PLC/SCADA/BMS/EMS systems) Experience in trouble shooting for automation and control systems Drive and Lead Automation (DCS/PLC/SCADA/BMS) Projects Technical understanding and experience in of automation platforms, such as Delta V, Honeywell, Rockwell PLC, Siemens XFP Facilities, Utilities, and Equipment (FUE) qualification Unit operations automation qualification with Honeywell, Delta V, and PLC-based systems Computerized systems validation Support to change controls, investigations, deviations, and CAPAs Ability to effectively lead validation projects, coordinate contractors, junior level personnel and drive results Working closely with the systems integrators, automation leads & process leads Completing the FAT, SAT's, IQ, OQ. creating and executing the protocols & documentation Knowledge of E2500, V Model concepts along with GAMP5, S88, S95 Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments Must be able to solve routine problems with assistance. Strong organizational skills, excellent writing and communications skills Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus Ability to travel up to 50% or more within and outside Malaysia Large scale project experience Valid Passport with no restrictions to travel Education Engineering degree in Automation, Instrumentation, EEE, ECE