Role & responsibilities

- Projects
- Senior, technically qualified, hard core Pharma experienced professional , responsible for high standards deliveries in the areas of Engineering, utilities, infrastructure, Projects in the entire spectrum of high end pharmaceutical manufacturing business.
- Qualified Engineer & Management skilled with B.Tech / M Tech , Mechanical/ Electrical qualification
- Have an extensive experience in Green field/Brown field project activities in Pharmaceutical industry both in Formulations & Biotechnology , API industry experience is an added advantage
- -To take on planning in sizing the plant, Implementation of plan from concept to commissioning
- - Design to meet the Statutory & Regulatory guidelines,

- -Effective implementation of challenging tasks, where processes and ideas are converted in to design , Safety, cGMP & capacity
- Capacity & Performance optimization skills of useful for brown field projects design, detailing, validation

Preferred candidate profile

- With 15-18 years of experience in Projects, in different positions with vide responsibilities in Formulation Units, and Green field projects of Formulation OSD ,Topical ,Soft gel, Injectables, of potent / non potent products with Bio Technology experience is an added advantage
- As Infra Project lead involved in Concept notes, with master plan preparations, Infra expansions plans for manufacturing of Formulations , then to Basic, Detailed Engineering, Procurement Planning , Execution and subsequent Qualifications/ Validation activities in both Formulations in general . Hands on experience in implementation of
- Familiar with Aseptic Filling / Terminally Sterilized vial filling equipment and Isolation / RABS of the M/C
- Familiar with Biologic API product Mfg Project
- Familiar with EduRox guidelines with ISO 14644 standard for clean room designs
- Handled good size of team in Green field Project execution
- Familiar with Safety practices in construction and Operational safety
- Familiar with Statutory, Schedule-M requirements in Projects function




- Familiar with Oncology , Harmon, Potent, Steroid requirements in design and execution
- The Contained facility experience in Solid Oral Dosage ( SOD) facility , Injectable facilities
- Constructing and commissioning of Biologic Manufacturing unit with complete DCS system
- R&D; center with Animal house ,housed Formulation development lab , and Analytical R&D; Center for development of Bioequivalence testing center and development of generic OSD drugs
- Construction of Ware houses with AS/RS,
- Involved in concept note development, FEED , Basic engineering , Detailed Engineering, VMP of facility , and Qualification activities of Manufacturing facilities
- Concept development and Basic design with consultant
- Detailed Engineering of facility
- Actively involved in Procurement process of all packages
- Land development work ,Integrating to Master plan of entire site
- All Statutory approvals for project like CFE, Factory license , Mfg Drug license, CEIG etc..
- Cost estimations & tracking of expenses Budget Vs actual + commitments at WBS level Formulation Project
- Coordinating for validation of processes & Qualification of facilities & Equipment activities to Validation team
- Building the team , for project & then in operations Involved in concept note development, FEED , Basic engineering , Detailed Engineering, VMP of facility , and Qualification activities of Manufacturing facilities
- Power distribution system 11/33 /122KV transformer yard to suit as per the statutory norms / erection & commissioning of 33KV Transformer yard
- Develop and review technical document, URS , P&ID;, FAT, SAT and other specification document and obtaining Client approval
- Plan, participate and execute the equipment start up, commissioning, qualification and validation activities.
- Coordinate & interact with internal / external consultants and contractors for mechanical installations work
- Provide recommendations & contribute on equipment design , code compliance, operational ease & maintainability
- Contribute and participate for preparation and execution of GMP activities (DQ, IQ, OQ , and preparation of SOP etc.).

📌 PMO - Formulations - Project Head (Hyderabad)
🏢 Standard Group of Companies
📍 Hyderabad