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Process Subject Matter Expert Sterile Injectable

15.00 to 20.00 Years   Gurugram   25 Apr, 2019
Jacobs Engineering India
Job LocationGurugram
EducationNot Mentioned
SalaryNot Disclosed
Industryngineering / Construction
Functional AreaProcess Control
EmploymentTypeFull-time

Job Description

Subject Matter Expert Process Sterile Injectable is responsible for:

  1. Timely completion of designs, and Process engineering deliverables.
  2. Adherence to Deptt/Discipline Working Instructions and Quality Systems.
  3. Should possess a very strong communication skills
  4. Should have innovative ideas which bring value to client.
  5. Overview of work progress and work-hour usage.
  6. Working within company budgets
  7. Meet client expectations and maintain long-term relationship with client. Attend to client s feedback and any complaints
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.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:
  1. Routine calculations by use of computer
  2. 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:
  1. Project Manager and/or Engineer are aware of problems of progress delays.
  2. Proper interchange of information.
  3. Proper interchange of documents
  4. Interface 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., 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 following:
  • Performing 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 preparation
  • Exposure of simulation software s 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 Reviews
  • Process engineering calculations such as Thermal rating of heat exchangers, and hydraulics.

Keyskills :
systempidengineeringmappingprocessubjectdiagramsterileformulationinjectableflowmattercapacitylyophilizerexpert

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