PMO - Formulations - Project Head

Standard Group Of Companies; Hyderabad; On-site; INR 400,000 - 650,000; Full time

Job summary

Standard Group Of Companies in Hyderabad seeks a senior, technically qualified pharma projects professional responsible for engineering, utilities, infrastructure, and manufacturing facility projects across Formulations and Biotech contexts.

You will lead planning, design, procurement, commissioning, qualifications, and validation activities, ensuring cGMP compliance, safety, and on-time delivery in a complex, regulated environment.

Qualifications

• Extensive experience in pharma project design and execution.
• Proven track record in greenfield and brownfield facilities.
• Knowledge of regulatory guidelines and cGMP standards.
• Lead cross-functional teams across engineering, utilities, and QA.

Responsibilities

• Plan plant sizing and implement plans from concept to commissioning.
• Lead design to meet regulatory guidelines and safety standards.
• Coordinate with internal/external teams for installation and validation.
• Oversee procurement planning and execution of infra expansions.
• Drive QA/Validation activities (DQ/IQ/OQ) for facilities.
• Ensure compliance with Schedule-M and related regulations.
• Develop master plans and FEED documentation.

Skills

Project management

Engineering

Regulatory compliance

cGMP

Safety practices

Team leadership

Infra planning

Facilities design

Education

B.Tech / M.Tech in Mechanical/Electrical

Tools

P&ID

URS

FAT/SAT

DCS systems

RABS

Job description

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 professional 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.).