Process Director - Pharmaceutical / BioTech / Lifesciences

Candidate should have knowledge of following : .

• Performing process calculations like heat & mass balance, Utility sizing for API, OSD and Biotech Projects.
• Pharma Process Equipment data sheet preparation.
• Line sizing, relief load & PSV calculation.
• Exposure of simulation software's such as HYSYS, ASPEN.
• Preparing Process Flow Diagrams (PFDs) and Piping and Instrument Diagrams (P&IDs).
• Reviewing all aspects of design and construction for consistency and safety, including leading Hazop and PHA Reviews.
• Process engineering calculations such as Thermal rating of heat exchangers, and hydraulics.
• Candidates should be able to carry out Capacity Mapping of Biotech Projects using Schedule.
• Pro and Super Pro.
• Should have a very strong knowledge on layout designing of API, OSD, Sterile and Biotech.
• Should possess sound knowledge on Area classification and man material flow concepts.
• Should have knowledge on latest ISPE Guidelines.
• Should be well aware of regulatory requirements of USFDA, MHRA, and WHO etc.
• Should possess a sound knowledge on equipment selection criteria like.
• Fermentation, Bioreactors, TFF, Chromatography, Filling Lines, etc.
• Knowledge on Disposable Technology will be an added advantage.

MEASUREMENT AND PERFORMANCE :

• Through regular contact with discipline and project personnel and by regular review of the project status reports, ensure upto-date and reliable statistical information on project performance.
• Improve the productivity by means of reduction of rework and errors.

RESPONSIBILITIES :

• Review technical requirements of client's specifications and ensure that agreement is reached on the basis of design.
• Participate in discussions with the client, as necessary.
• Investigate, analyze and implement systems, and methods to improve efficiency and accuracy.

These investigations include : .

• Routine calculations by use of computer.
• Monitoring latest developments and latest techniques in his area of functioning.
• Monitor that work and progress are in compliance with the project requirements and schedule.
• Maintain contact with other disciplines / groups to ensure : .
• Project Manager and / or Engineer are aware of problems of progress delays.
• Proper interchange of information.
• Interface is correctly defined.

(ref : iimjobs.com)