Teva Pharmaceutical - Associate Director - Design Engineering - Pharma API

Primary purpose of the position

- You will Drive Engineering standardization in TAPI and establish consistent engineering approach across the network according to Teva's and industry's standards

- You will be working on engineering projects across different Global Sites of TAPI, in particular on all pre-project phases (master plans, programs, preliminary studies, conceptual design) as an Design Manager-TAPI. You will be part of Teva internal Global Design teams based in Mumbai and will be working in collaboration with project manager, TAPI R&D, TAPI MS&T and TAPI EHS.

- Design Manager- TAPI is experienced with all basic unit operations utilized in the manufacturing of API products. The ideal candidate will have process design and operations experience working on API facilities. You will be accountable for conceptual and basic engineering design for all major API projects in TGO and drive the department for standardization and consistent engineering approach in the network.

General duties and responsibilities

Your main responsibilities will be:

1. Write Engineering standards and guidelines for TAPI's technology

2. Drive conceptual and basic design for strategic projects in TAPI and for New technologies. Working closely with project manager, GE's Design team, TAPI R&D, TAPI MS&T and TAPI EHS

3. Support sites for master planning and preliminary studies. Approve basic design (CERs) for projects >500K$

4. Drive knowledge sharing program and professional forums across the network

5. You should lead the Conceptual Design of API production projects from the initial ideas to a firm basis for decision and there on to proceed in subsequent project phases.

6. Develop new or expansion within existing production units by ensuring the following steps:

- Data collection and processes analysis

- Generate conceptual design deliverables such as Process Flow Diagrams, Process Descriptions, Containment Philosophies, as well as Material and Energy Balances.

- General arrangement planning and development of Layout including Risk analysis of the facility.

- Preparation and writing of Process Equipment URS, SOP's and Risk analysis including their Standardization.

- Analysis of different discipline support functions and constructability review

7. Generate Process P&IDs (preferably on AutoCAD) that include controls strategy and CIP functions, if appropriate. Also, generate P&IDs for critical utility systems, such as USP Purified water.

8. Performing process calculations like heat & mass balance, Utility sizing.

9. Candidates should be able to carry out Capacity Mapping of Equipment including reactor sizing.

10. Should have a very strong knowledge on layout designing of API production Plants.

11. Should possess Expert knowledge on Area classification and man material flow concepts.

12. Should have thorough knowledge on containment techniques and should be aware of carrying out Containment Studies.

13. Should have in depth knowledge on latest ISPE Guidelines.

14. Should be well aware of regulatory requirements of USFDA, MHRA, and WHO etc.

15. Ensure use of GMP,QMS,QBD and global mandatory standards and guidelines wherever possible

16. Should possess an expert knowledge on equipment selection and should be able to guide the team on Process Equipment data sheet preparation

17. Produce specifications and performance data sheets for process equipment and instrumentation.

18. Ideal candidate should be able to demonstrate - Life cycle costing- & - Total cost of Ownership-

19. Planning, risk and cost evaluation

20. Preparing presentation material that helps Teva's Internal Stake holders in strategic decision making and subsequently engineering concepts.

Qualification/Skills

1. Minimum of 15-20 yrs. in process design in the Pharmaceutical industry.

2. Bachelor's Degree in Chemical Engineering or Mechanical Engineering.

3. Candidate should have exposure on working on international projects across the Globe; especially in Europe and US.

4. Knowledge of how cGMP's affect process design and equipment specification.

5. Progressive ability, capacity and aptitude in administration to plan, organize, supervise and coordinate technical work while obtaining cooperation from others. Analytical thinking, structured problem solving skills, superior communications skills, team building and strong work ethic.

6. Site master planning and conceptual design for major capital projects (Greenfields and Brownfields)

7. Understanding of Regulatory and Documentation compliance requirements (GMP and EHS)

8. Demonstrated knowledge of GEP

9. You are rigorous, independent, and curious, with good communication skills and the ability to manage projects in an international context. You are able to demonstrate the ability of persuasion and listening.

10. You are flexible and ready to travel a lot if needed.