Process Manager should have a strong understanding of Pharmaceutical Projects for all dosage forms of OSD, Sterile, Topical and Liquid Manufacturing products (Cytotoxic Product will be an advantage). Should have a firm hand on experience into the Feasibility, Process Study, Process Risk Analysis, Concept Designing for Pharma Projects. Well versed with relevant guidelines like EU GMP, US FDA, PIC/S, Schedule M, ISPE, cGMP, GSP, GLP, ISO, GxP, 21 CFR, Indian Pharmacopeia (IP), British Pharma-copeia (BP), US Pharmacopeia (USP), etc. Should have handled at least process of pharmaceutical manufacturing project and Laboratory with Microbiology. Self-Starter, motivator, team player. Will be independently dealing with the Client, Vendors and Suppliers, internal resources apart from Project Management, Project Progress Reports & necessary Reports to the project team.
Essential Duties & Responsibilities
- Provide effective leadership, coaching and conflict resolution to the project team in order to meet project goals and objectives
- Independently capable of doing process flow diagram, batch size calculation, process balance, equipment sizing, working area calculation, risk analysis, FMEA, VMP, CQV, QMS, etc.
- Independently capable of preparing URS for process equipment. Review of DQ documents, GAD, etc. of the vendor as per required process and guidelines.
- Coordinate multi-discipline for providing the utility requirements for the process equipment.
- Independently capable of doing time cycle charts for the clean utilities.
- Contribute to Standards and Guidelines Development (Providing Project Concept notes as per latest selected guide lines), Upgrade and comply latest (world class) standards and modifications in all projects.
- Manage relations with international clients and have willingness to travel.
- Independently capable of doing FAT, SAT, DQ, IQ and OQ.
- End responsibility within our projects for all Process Engineering from the quotation phase, over design till qualification and handover to the client in projects for Pharmaceutical.
- Having knowledge of process automation and optimization.
- Preparation and review the layouts in the process perspective and understanding the client’s process requirement.
- Act as SME for process & equipment, driving requirements in the design/selection of process equipment.
- Follow and anticipate process technology and design industry trends and knowledge transfer to the team.
- Manage relations with international clients and have willingness to travel.
- Preparation of PFD (Process Flow Diagram) and P&IDs (Piping & Instrument diagram) for Process.
Required Skills and Experience
Education
BE Mechanical or any Engineer/B. Pharm / M. Pharm / PhD from Government College / Regional College (REC) / any other College of repute.
Experience
Min 10-15 years of total professional experience in Process design and execute pharmaceutical projects either with a pharmaceutical company’s technical organization or with an engineering/consulting company.
Functional Competencies
- Process Design
- Planning & Execution
- Knowledge of cGMP, ISPE, GSP, GLP, ISO and other engineering guidelines etc.
- Good Command over AutoCAD + MS Project
- Ability to handle team effectively
Behavioral Competencies
- Result Focus
- Innovative thinking
- Time Management
- Problem solving ability & High level of self-motivation
- Strong inter-personal relationship skills
- Strong written & verbal communication
Draughtsman should have a strong understanding of Pharmaceutical Projects for all dosage forms including Sterile & Oncology. Should be responsible for collaborating with Project Manager & Project Engineer to develop mechanical designs from concept through detailed drawing for Pharma Projects. Well versed with relevant guidelines like cGMP, GSP, GLP, ISO etc. Self-Starter, motivator, team player. Exposure to ERP / SAP will be an added advantage.
Essential Duties & Responsibilities
- Optimal project designing with focus on standardisation of drawing elements, cost effectiveness & GMP compliances
- Develop mechanical drawing from concept through detailed designs
- Detail drawings in AutoCad to meet or exceed the clients’ needs, budgets and expectations.
- Update and modify drawings in AutoCad basis on inputs received
- Drawing Numbering and marking revision in drawing
- Visit to factory for FAT & Packaging and suggested and ensured Vendor to improve quality.
- Review project report status on a weekly basis
Required Skills and Experience
Education
Diploma / ITI – Mechanical from recognized board of technical education / Government Engineering College / any other Engineering College of repute.
Experience
Min 4-8 years of relevant experience with a pharmaceutical engineering/consulting company.
Functional Competencies
- Good Command over AutoCAD
- Knowledge of cGMP, GSP, GLP, ISPE, ISO,EMA etc
Behavioral Competencies
- Result Focus
- Innovative thinking
- Time Management
- Problem solving ability & High level of self-motivation
- Strong inter-personal relationship skills
- Strong written & verbal communication
Utility Manager should have a strong understanding of Pharmaceutical Projects for all dosage forms including Sterile & Oncology. Should have a firm hands on experience into the Design of both Clean Utilities from water pre-treatment, final treatment, Storage and Distribution as per various guidelines and Black utilities like sizing and selection of Chillers, Boilers, Cooling tower, Air compressor, etc. Pipe & Component selection, sizing and generating BOM and costing. He will lead a team of engineers for ensuring the delivery of all pharma projects. Well versed with relevant guidelines like cGMP, ISPE, USFDA, ASME, GSP, GLP, ISO etc. Will be independently dealing with the Client, Vendors and Suppliers and internal resources. Knowledge of site execution, installation & commissioning, is value added.
Essential Duties & Responsibilities
- Responsible for design (Concept / Basic / Detail) of the Utility systems
- Preparation of Concept Document related to all Clean and Black Utility
- Conversant with Utility design for pharmaceutical facilities such as OSD, OLD, OCL, sterile in compliance with various guidelines like cGMP, WHO, ISPE, and other engineering guidelines etc
- Preparation of technical specification of each utility equipment
- Design Equipment Layout, Piping Layout
- Preparation of GA Drawings, Piping Isometrics, Support Drawings with Bill of Material
- Preparation of standard P&ID’s with respect to design
- Responsible for reviewing and approval for design specification prepared by design engineers and ensures the quality of work done
- Coordinate with other engineering disciplines and project team functions to assist in managing engineering execution and project management deliverable
- Identification of new vendors, consultants etc. to fulfil the project specifications time to time
- Participation of tender specifications and BOQ.
- Design detailing of all pipeline as per ASME guideline.
Required Skills and Experience
Education
B.E / B. Tech – Mechanical from Government Engineering College / Regional Engineering College (REC) / any other Engineering College of repute.
Experience
Min 10-15 years of total professional experience in designing of various utilities including its distribution etc. for pharmaceutical projects either with a pharmaceutical company’s technical organization or with an engineering/consulting company.
Functional Competencies
- Exposure to BMS & EMS system is required.
- Should be aware with execution of Clean & Black Utility systems and drawings
- Knowledge of cGMP, ISPE, WHO, ASME etc
- Good Command over AutoCAD + MS Project
- Planning & Execution
Behavioral Competencies
- Ability to handle team effectively
- Result Focus
- Innovative thinking
- Time Management
- Self-motivation & Problem-solving ability
- Strong inter-personal relationship skills
- Strong written & verbal communication
Executive Projects will support the execution of pharmaceutical facility projects, including Sterile, OSD, and Oncology dosage forms. The role involves assisting in project planning, coordination with internal teams, vendor management, and documentation. The candidate should have a good understanding of engineering fundamentals, layout review, and basic compliance with regulatory guidelines such as cGMP, ISPE, GSP, GLP, and ISO. The role requires strong coordination and documentation skills. Exposure to ERP systems and project planning tools is an added advantage.
Essential Duties & Responsibilities
- Assist the project team in preparing layouts, technical specifications, BOQs, and
engineering documentation.
- Coordinate with internal departments (HVAC, Electrical, Cleanroom, Utilities, Automation) for gathering design inputs and aligning engineering deliverables.
- Track project progress, follow up with vendors/suppliers for timely documentation and dispatches.
- Participate in technical discussions, design reviews, and vendor meetings under supervision.
- Maintain project-related records including technical submittals, approval sheets, minutes of meetings, and progress reports.
- Support project team during execution phases including installation, commissioning, and validation coordination.
- Prepare and update project trackers and assist in creating presentations or reports for internal and client meetings.
- Follow up on drawing submissions, material delivery schedules, and documentation closures.
- Assist in organizing FAT/SAT activities in coordination with vendors and project engineers.
- Ensure project documentation is aligned with applicable quality and compliance standards.
Required Skills and Experience
Education
B.E / B. Tech – Mechanical / Chemical from Government Engineering College / Regional Engineering College (REC) / any other Engineering College of repute.
Experience
Minimum 2–4 years of professional experience in design and execution of pharmaceutical projects with a pharmaceutical company, EPC contractor, or engineering/consulting firm.
Functional Competencies
- Basic understanding of pharma facility design and project execution
- Familiarity with engineering drawings and layouts
- Knowledge of cGMP, ISPE, GLP, GSP, ISO guidelines
- Working knowledge of AutoCAD and MS Office (Excel, PowerPoint)
- Exposure to ERP systems preferred
Behavioral Competencies
- Good communication and coordination skills
- Attention to detail and documentation accuracy
- Time management and ability to multitask
- Positive attitude and willingness to learn
- Team player with accountability
- Strong follow-up and problem-solving skills
Assistant Manager – Projects should have a sound understanding of pharmaceutical projects for all dosage forms including Sterile and Oncology. The candidate should have hands-on experience in Concept Designing, Basic Engineering, and Detailed Engineering of pharmaceutical facilities, with exposure to relevant guidelines such as ISPE, cGMP, GSP, GLP, and ISO. The role requires effective coordination with clients, vendors, and internal teams to ensure timely and quality execution of project deliverables. Exposure to ERP and project planning tools is desirable. Candidate should be a self-motivated team player with the ability to support Project Leads and handle assigned project scopes independently.
Essential Duties & Responsibilities
- Assist Project Managers in planning, coordinating, and executing pharmaceutical projects across all phases – from design to final handover.
- Prepare and review project engineering documents such as layout plans, technical specifications, BOQs, and data sheets in coordination with the design team.
- Support in developing and tracking project schedules, milestones, and deliverables using project management tools (e.g., MS Project).
- Coordinate with internal cross-functional teams (HVAC, Cleanroom, Utilities, Electrical, Automation, etc.) for seamless integration of engineering deliverables.
- Liaise with clients, vendors, and contractors to ensure technical and commercial alignment during project execution.
- Monitor daily project activities and provide updates to senior management and clients through progress reports and dashboards.
- Participate in vendor meetings, design reviews, and site coordination activities.
- Support the preparation of project documentation for quality, validation, and compliance.
- Ensure adherence to project timelines, budgets, and quality benchmarks.
- Assist in conducting FAT, SAT, installation, commissioning, and validation activities as required.
- Maintain comprehensive documentation and records for audit and compliance purposes.
- Identify potential project risks and assist in developing mitigation strategies.
Required Skills and Experience
Education
B.E / B. Tech – Mechanical / Chemical from Government Engineering College / Regional Engineering College (REC) / any other Engineering College of repute.
Experience
Minimum 6–10 years of professional experience in design and execution of pharmaceutical projects with a pharmaceutical company, EPC contractor, or engineering/consulting firm.
Functional Competencies
- Good understanding of pharmaceutical project design and execution
- Project planning and coordination skills
- Familiarity with cGMP, ISPE, GSP, GLP, ISO and other regulatory requirements
- Working knowledge of AutoCAD and MS Project
- Exposure to ERP systems preferred
Behavioral Competencies
- Strong written & verbal communication
- Effective team coordination and collaboration
- Time management and organizational skills
- Result-oriented and proactive approach
- Problem-solving ability and attention to detail
- High level of self-motivation and accountability
- Interpersonal and client handling skills
