Process Director - Pharmaceutical/BioTech/Lifesciences

- A degree in Chemical Engineering Discipline with Minimum 18 to 20 years in Process Department of a consultancy organization or technical services department of a Pharmaceutical/ Biotech/Lifesciences.

- Candidate should possess knowledge in carrying out basic and detailed engineering work.

- The experience can be from any Pharmaceutical/ Biotech/ Chemical projects.

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.