Process Manager

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

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