Client Company: I USA based MNC Pharma Company established in 2006 in Vadodara, Gujarat & having it's headquartered in New Jersey. Company is leading process R&D & API manufacturing service provider for worldwide pharmaceutical industry. It offers a wide portfolio of services ranging from APIs for the generics industry to custom synthesis for early phase pharmaceutical research & branded products. it is a small scale developer and manufacturer of specialty APIs and cGMP advanced intermediates. it has USFDA-approved facilities. In the USA, the Somerset, NJ facility can produce a few grams up to 200Kg volumes and in India, the Vadodara; Gujarat facility can produce a few Kg to a few metric tons up to 60 MT/yearly. Both facilities are equipped with state-of-the-art analytical and research capabilities. Job Location: Vadodara, Gujarat Numbers of Positions: 1 Sr. Manager - Engineering & Maintenance (API) Job Profile: Projects: Execution of projects dealing with erection & commissioning of plant equipment like Reactors, Centrifuge, Dryers, Blenders, Milling machine, Vacuum systems, Pumps, Piping, HVAC Systems, Water System, Cooling Tower , Compressors & ETP equipment. Planning & scheduling to ensure execution of project within time. Effective site management & monitoring the progress of work in terms of resources deployment, time over runs & quality compliance. Co-ordination with external & internal partners for handling technical queries, work schedule & design related problem. Inspection of various equipment at suppliers site. Ensuring compliance with cGMP requirements with QA people & consultant for securing FDA license & clearance . Operation & Maintenance: Ensuring smooth operation of Utility & plant equipment to maximize production & to meet pre-set production target. Ensuring the proper availability of utility services at plant level. Monitoring operational parameters of utility equipment to ensure adherence to the technical specifications. Planning & implementing effective Preventive maintenance Schedule to enhance equipment reliability & up time. Immediately handle the break down maintenance with fast decision & proper manpower to reduce the down time. Documentations: Maintaining the routine documents for ISO 9001 & 14001. Preparation of Documents for USFDA like Design Qualification, Installation Qualification, Operational Qualification & SOP. Material management & vendor Development Identifying & developing alternate vendor sources for cost effective procurement of equipment, spare parts & raw materials. Devising & implementing systems for effective materials & store management to ensure ready availability of various requirements. Working Area: Handling and maintenance of the following equipment: Chilling Compressors, VAM, Reverse Osmosis Plant, Steam Boiler, Air Compressor, Nitrogen plant and D.G. Set etc. Reactors, Centrifuge, Different types of Dryers and other Pharma equipment. Piping and commissioning of the system. Hydraulic system and pneumatic system. Different types of pumps, Gearboxes, Valves and Heat Exchangers. Material Handling Equipment like Diesel Forklift, Hydraulic trolley, etc. Client Company: II Company is a leading & trust worthy Pharma Contract Research Organization & Outsourcing Partner offering a full custom designed development services with professional standards to customers globally within the timeline without compromising quality. Company is a professionally managed organization provides all types of Pharma services in Formulation & API, having formulation development as main forte. Formulation Development is a the core activity at Company & it includes Pre-formulation studies, Formulation Development, Analytical Research & Development, Stability Studies, Dossiers Preparation & Technology Transfer etc. Formulation Development is based on QbD/DoE principles as per USFDA/EMEA expectations. Company is a providing formulation development services for different Pharma formulations like: Tablets & Capsules (IR, SR, ER etc.), Mini & Bilayer Tablets, Fast Oral Disintegrating Tablets & Strips, Matrix & Coating Formulations, Topical Formulations (like: Creams, Gel, Lotion, Ointment, Otic), Oral Liquid Formulation (like: Suspension & Syrup), & Injectables, Lyophilized & Ophthalmic & High Potent Molecules. As an outsourcing partner, Company connects buyer & sellers within the Pharma industry & provides strategic advantage to various pharmaceutical companies across the globe. Company is strong in providing outsourcing services for formulations, API & Intermediates as per country specific requirements. Company also provides outsourcing of fine & Specialty Chemicals, Drug Impurity Standards, Isotope Labelled Compound. Company is established with a view to provide comprehensive scientific solutions for various Pharma industries & enterprises like: Formulation Development, Analytical Development, Process Development / Synthetic Research, Regulatory Service, Quality Assurance & Compliance, Clinical Support, Project Management, Engineering Services, Outsourcing Services. Company is a start up company incorporated by well known people from Pharmaceuticals Industry in 19th June - 2015. Company has it's headquartered in India & working across the word. Company has its R&D Centre at A-310, MIDC, TTC Industrial Area, Mahape, Navi Mumbai, Maharashtra. For the Employees & Team Members, Company offer startup culture, Flat Organization Structure, Flexi Hours, Liberal Leave Plans, International Exposures Health Insurance, Continuing Education Support, On-Campus Library, Career Development & Family Career Plant. Job Location: Mahape, N'Mumbai Numbers of Positions: 1 Manager - Projects Engineering Job Profile: Layout Design of Pharmaceutical Formulation Plan & API Plant. Conceptual Layout & Basic Layout. HVAC & Water Plant Design & Execution. Mechanical Piping Work & Electrical Work with LT & HT Panel. Utility Engineering work like: Boiler, Chiller Plant, DG set. Technical Comparison. Documentation, SOP, Protocol as per cGMP. Plant Maintenance of OSD machine like: Compression, Coating, FBP, RMG, Packing Machine. Preventive Maintenance & Breakdown Maintenance. Budgeting for Plant. Vendor Assessment. Man & Material Movement.