C&q Engineer

Summary -EngineerExecute engineering activities design implementation maintenance etc within technical area of expertise by using reliable and cost effective technical solutions ensuring technical quality to enable the overall site project objectives Maintenance Technician IIResponsible for execution of maintenance And calibration activities and commissioning activities for projects at site level Process Engineer Supervise plant engineering team providing technical assistance to the function and ensuring that the best possible maintenance repair and or modifications are undergoneOther positions Execute for design execution and hand-over projects within cost time schedule quality and functionality withintechnical area of responsibility Key Responsibilities Responsible for Preparation execution compiling of Facility Process HVAC Clean room and Utility Services Commissioning Qualifications activities Protocols reports for the Pharmaceutical facilities which includes OSD Injectable API Oncology Biotechnology Vaccine manufacturing facilities Responsible for onsite support C Q activities by following ISPE ASTM methodologies utilizing GDP GEP C Q Base line guides GAMP 5 cGMP Principles Planning developing execution reporting of C Q Deliverables Coordination with different package design engineers Clients Project managers to enable effective leveraging and timely Right First Time Documents preparations execution and compliance of Commissioning Qualification deliverables In depth knowledge of Regulatory Guidelines- USFDA MHRA WHO ISO 21 CFR part 11 other regulatory guidelines Preparations of Commissioning Qualifications Protocols Standard operating Procedures Work instructions as applicable Prepare Review of Validation master plan Validation plans Validation Documents Commissioning Validation execution of Clean Room HVAC Systems Such as DQ IQ OQ PQ in Pharmaceutical Industries as per the required standards Preparation and review of qualification protocols Temperature mapping protocols Layouts and SOPs as per established procedures Preparations execution of Pre-commissioning Commissioning checklists for various systems including Facility Process Utility Equipments Preparation execution of Facility Utility process equipment FAT SAT Protocols Reports Essential Requirements Degree in Mechanical Chemical Engineering with 5-8 years of experience in Pharmaceutical Chemical FMCG Industry Deep understanding of Project Commissioning Qualification activities like Facility HVAC Clean room Black Clean Utility services Process equipment within pharmaceutical OSD Injectable API Oncology Biotechnology Good Knowledge of Project management like - Project planning Cost Management Time Management Construction management Quality Management Contract Administration Safety Management required Statutory approvals management Desirable Requirements Degree in Mechanical Chemical Engineering or equivalent Fluent in English and proficient in local language Skills Desired Agile Programming Methodology Architectural Engineering Aws Amazon Web Services Business Continuity Business Networking Change Control Computer Science Construction Management Cost Management Flexibility General Hse Knowledge HVAC Heating Ventilation And Air Conditioning Including Gdp Installations Computer Programs Knowledge Of Capa Knowledge Of Gmp Knowledge Of Relevant Tools And Systems Manufacturing Production Project Commissioning Project Engineering Project Execution Risk Management Root Cause Analysis RCA Software Development Total Productive Maintenance