Completing capital projects (new projects/project expansions/up-gradation of existing facilities) on time and within the approved budget.
Developing a strong documentation package, involving from conceptual study to various phases of project like basic engineering, detail engineering, pre-commissioning / commissioning of equipment.
Responsible for preparation of various regulatory inspections/audits and need based active participation during audits
Responsible for timely completion of projects to meet the company objectives.
Responsible for qualification and documentation related to engineering department.
Responsible for workload forecasting and ensuring effective work processes& procedures are in place and are being followed / used by all the team members.
Maintain awareness on HSE requirements and implementation of the same as per group policies, rules & regulations.
Accurate estimation of budget for CAPEX and managing the same within the approved budget.
Conduct regular project review meetings within the team, with cross functional teams and with the vendors to control the project time to time.
Responsible to build good working relationship with cross functional and inter departmental teams to lead the entire project team of all disciplines.
Responsible to lead a team of people at all levels and guiding them in right direction towards organization requirements.
Required Technical Competencies- Essential:
Experience in developing Block Flow Diagrams, Process Flow Diagrams, Piping and instrumentation Diagrams, Mass and utility balances, safety analysis etc of bio pharmaceutical processes
Should have hands on experience in conceptual, detailed design, project planning, execution and qualification of biopharmaceutical facilities as per cGMP requirements.
Should have hands on experience with process valve matrix, process sequence logics, functional design specification ( FDS), process control sequences, CIP/SIP sequences etc...
Working experience in reviewing/development of URS, Tendering, preparation of technical comparisons, DQ, FAT, recipient of equipment, SAT, commissioning, qualification and closeout of Biopharmaceutical facilities.
Ability to work in a team structure- plan organize and prioritise work
Ability to analyse quantitative data, create and/or edit written reports and be able to process information.