Mechanical Engineer

Ensuring Timely execution of Green field/ brown field projects to facilitate smooth and safe site operations without impacting Cost and Quality norms.

3. Key Accountabilities

Major Activities / Tasks

I. Project charter / Concept note

 Proven working experience as a lead Project Engineer in Pharmaceutical (API) Green field & brown field projects.

 Assist in preparation of business case/ Project charter/ Concept note to User.

 Ensures the Equipment engineering support to different projects Tenders and job start-up.

 Develop plant layout and prepare plans for facilities and requirements.

 Estimation of cost for budgetary proposal which includes operational cost also.

 Introduction of New technologies in project.

 Recommendation & Implementation of Energy Saving System /Equipment’s in new Project.

 Detailed knowledge of API Process & Utility Equipment like Reactor, Centrifuge, Dryers Isolators, Boiler, Chillers etc. in terms of design & functions.

 Should have Knowledge of HAVC system, documentation & guidelines related pharmaceutical standards. (e.g. USFDA, WHO ISO etc.)

 should have exposure to USFDA and other regulatory agencies.

 Excellent knowledge of design and visualisations software such as AutoCAD.

 Advanced in MS Office skills, MS Project Software.

 Knowledge of International codes like ASME, ASTM, Hygienic piping engineering (Process, water system, Clean steam, Utility etc.)

II. Approval and Evaluation  

 Ensure statutory approval / Regulatory approval during each stage of project.

 Coordinates the evaluation of the design changes to the original scope of work and verify the implementation of those approved.

 Evaluation of consultant and consultancy CER preparation.

 Technical evaluation of Vendors to meet Cipla specification and standards

III. Project Planning

 Preparation of URS/ RDS/Technical specification sheet/ Terms of reference/layouts and drawing.

 Carry out Risk assessment in coordination with Safety/ User.

 Preparation of bar chart /project schedule along with major Milestone.

 Submit the CER and follow for approval.

IV. Project execution and Monitoring

 Delivery of the project in accordance with the project deliverables & schedule.

 Follow up with the purchase department and supplier to get the required material in time.

 Co-ordinates with contractors and sub-contractors for scheduling of work.

 Co-ordination with concerned department heads for timely execution of engineering activities.

 Monitoring and tracking of all activities ensuring time, cost , quality are maintained.

 To ensure that the all safety norms followed by the contractors at the time of Mechanical work.

 Monitor compliance to applicable codes, practices, QA/QC policies, performance standards and specification.

 Asist in FAT/SAT as per URS.

V. Communication

 Timely communicate project status to concerned stakeholders

 Conduct daily PD with Contractor and work assignment

VI. Documentation and Project Hand over and Post completion  

 To ensure GMP documentation completion for engineering scope of work.

 Handover of the project to user from engineering point of view.

 Identification of critical spares and inventory management

4. Key Interactions

Internal

External

 Safety for safety operations and near-misses

 Site head & Unit heads: Project progress communication

 Indirect purchase for Spares, scope, insurance and new vendors

 Central purchase for provide Technical inputs and clarifications for CAPEX (Need basis)

 User: Asist for project detailing and cost approval 

 OEMs for projects, automations, alternate vendor development, quality issues and maintenance (Need basis)

5. Dimensions

 Smooth transfer of projects

 No. of cross-site engineering meetings conducted

 Ensure Time, Cost and Quality requirement met as estimated

6. Key Decisions:

Decisions

Recommendations

 Vendor Recommendation

 New equipment recommendation

 Project costs (To head of manufacturing and finance)

 New vendor addition (To finance)

 Hiring consultants (To site heads)

Comments:

7. Skills & Knowledge

Educational qualifications:

 BE/B-Tech Mechanical with 12-15 years of Experience. Additional qualification like MBA will be added advantage.

Relevant experience:

 Ability to implement new techniques, deep understanding of manufacturing process, planning and organizational skills, prioritization multi-tasking, understanding of financial concepts like CAPEX, OPEX etc., knowledge of automation.