Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.

Candidate must have hands on experience in Werum PAS-X/FTPS development. Candidate shall work with end user team to establish requirement specifications e.g. URS, FRS Support the team in the business process mapping, requirements analysis, scope definition. Responsible for creating and revising batch records Extensive software Design, Develop, Commission, and Validate MES applications using MES platforms primarily on Siemens OpcenterTM, experience on other MES system such as Rockwell FTPS, Emerson SyncadeTM MES and/or Werum PAS/XTM, Aspentech, Rockwell etc. will be added advantage. Act as a Subject Matter Expert for Design and Development of workflows, and various MES components such as EBMR, Document Management, Material Management, Training, and Equipment Tracking and Monitoring. Device interface mechanism with various software packages such as Laboratory Information Management System (LIMS), Quality Management Systems (QMS), and PAT etc. Lead cross functional meetings to gather requirements, scope, and business rationale for MES projects. Facilitate design review workshops with process subject matter experts. Offer remote support to overseas projects. Communicate proactively with peers, customers, and management - highlighting and resolving issues, proposing solutions and driving project to completion. Excellent problem solving and analytical skills Conduct training and share knowledge with team members Position requirements: Professional Experience: Experience of design, development, and deployment experience in SIMATIC IT eBR will be preferred, experience on other MES system like Rockwell FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech, and/or Rockwell etc. will be added advantage. Thorough understanding of ISA S88 and S95 models. Knowledge of Pharmaceutical manufacturing process will be an added advantage. Hands-on experience on Distributed Control Systems such as PCS 7, Emerson DeltaV or similar will be an added advantage. Knowledge of Computer Systems Validation, SDLC methodologies and GAMP is must. Excellent written and verbal communication skills. Ability to work within a team, lead cross-functional teams, and work independently in dynamic environments. Willingness to travel for startup and commission activities Key Skills: FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech ISA S88 and S95 models Distributed Control Systems such as PCS 7, Emerson DeltaV Computer Systems Validation, SDLC methodologies and GAMP LIMS, QMS and PAT

Team manager with good leadership skills Design, configuration, integration and implementation of process control solutions for various industries Develop P&IDs and loop descriptions for various plants, processes, and/or equipment. Develop User Requirement Specifications. Develop software and hardware design specifications. Design, program, implement, test and document process control applications. Develop control system validation/testing protocols. Specify and purchase Siemens/Rockwell components, drives, and other electrical components and equipment. Develop electrical panel schematics. Manage automation projects as assigned. Monitor progress of projects. Install, test, and start-up control systems on-site Required Candidate profile A Bachelors degree in Electrical / Electronics / Instrumentation / Computer Science Engineering or equivalent combination of education and technical experience. A minimum of five (6) years of experience in either a consulting engineering firm or operating engineering environment. Thorough knowledge of process instrumentation and control systems. Knowledge of and familiarity with the National Electric Code (NEC) and international standards. Experience designing and programming control systems with emphasis on Siemens or Rockwell controls. Experience in commissioning and startup of control systems is required. Ability to work with plant engineers, external vendors, operators and management to manage projects and assignments is essential. Ability to troubleshoot control systems from the field element up through operator interfaces and databases. Experience with control system networking technologies and PC networking technology. Experience working with SQL Server, Oracle, or other relational databases. Any experience with Visual Basic scripting is a big plus. Excellent written and verbal communication skills. Strong interpersonal skills and the ability to work in a team environment. Ability to work effectively in a fast paced multi-tasking environment. Experience in biotech/pharma, water, wastewater, medical device, or the food industry is required. Experience with PLC, HMI, and SCADA systems is a plus Specific knowledge of cGMPs and batch process control in the life science industry with validation experience is a plus. Knowledge of 21 CFR Part 11 requirements is a plus.

Roles & Responsibilities: Use Job summaries, submittals and other project technical documentation to design control systems for large, custom industrial equipment. Systems typically are composed of PLC based control, motor controls, VFDs, remote I/O, multiple junction boxes and associated panels, cable interfaces, sensors and other devices. Create, update, and release for manufacturing: electrical schematics, interface identification drawings, cabinet layout drawings, I/O lists, drawing lists, bills of material, and P&ID's using AutoCAD. Conduct internal design review meetings with onsite based Project managers. Create final documentation packages for end users including schematics, documentation, and vendor component literature. Work closely with the Project Engineer, Electrical Engineer and to solve problems that may arise in the shop or in other areas of coordination. Any experience with development/maintenance of any PLC/SCADA applications will be a plus but not necessary. Direct, train and mentor Detailers or more junior Electrical Designers in the execution of their duties when required. Check all work completed by other team members for accuracy and compliance with the project work order. Qualifications: B.Tech - Electrical Electronics/Telecommunication Instrumentation Diploma Key skills: AutoCAD - Electrical Design Engineering Control panels PLC VFDs Motor control panels Sensors & Actuators