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Process - Subject Matter Expert - Sterile Injectable

Gurgaon, HR
Job Code:
  • Engineering & Construction
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Job Details

Subject Matter Expert Process Sterile Injectable is responsible forTimely completion of designs, and Process engineering deliverables.Adherence to Deptt/Discipline Working Instructions and Quality Systems.Should possess a very strong communication skillsShould have innovative ideas which bring value to client.Overview of work progress and work-hour usage.Working within company budgetsMeet client expectations and maintain long-term relationship with client. Attend to clients feedback and any complaints2 .MEASUREMENT AND PERFORMANCEThrough 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. Should be able to guide a team of Process Engineers so that output is obtained thru regular mentoring.3 .RESPONSIBILITIESReview 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 includeRoutine calculations by use of computerMonitoring latest developments and latest techniques in his area of functioningMonitor that work and progress are in compliance with the project requirements and schedule.Maintain contact with other disciplines/groups to ensureProject Manager and/or Engineer are aware of problems of progress delays.Proper interchange of information.Proper interchange of documentsInterface is correctly defined.Ensure that site problems viz. Technical Queries and Non-conformity Notices are dealt with effectively and expeditiously and also ensure competent staffs are available for site trouble shooting as necessary.Attend Design Engineering Management Review Meetings.Furnish administrative and technical directives to discipline personnel.1. MINIMUM JOB REQUIREMENTSA degree in Chemical Engineering Discipline with Minimum 15 years in Process Department of a consultancy organization or technical services department of a Sterile Injectable plant. Candidate should possess expert knowledge in carrying out basic and detailed engineering work related to Injectable plants. The experience should be in any Injectable projects. Candidate should have expert knowledge of followingPerforming process calculations like heat & mass balance, Utility sizing.Candidates should be able to carry out Capacity Mapping of Injectable Projects.Should have a very strong knowledge on layout designing of Injectable Plants.Should possess Expert knowledge on Area classification and man material flow concepts.Should have thorough knowledge on containment techniques and should be aware of carrying out Containment Studies.Should have in depth knowledge on latest ISPE Guidelines.Should be well aware of regulatory requirements of USFDA, MHRA, and WHO etc.Should possess an expert knowledge on equipment selection criteria for Filling Lines with RABS and Isolators, Lyophilizer, Formulation Systems etc.Knowledge on Disposable Technology will be an added advantage.Should be able to guide the team in GMP reviews.Should be able to guide the team on Process Equipment data sheet preparationExposure of simulation softwares such as HYSYS, ASPEN will be an added advantage.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 ReviewsProcess engineering calculations such as Thermal rating of heat exchangers, and hydraulics.
Degree: ME/ M.Tech./ MS (Engg/ Sciences)

Additional Degree: BE/ B.Tech (Engineering)

Experience: 15-18


Design | Hydraulics | Process/Chemical
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