engineer in pharma company

Job Description:

Job Profile Overview :

1. Reviewing Architectures, Control system.

2. Knowledge of Redundancies, higher ended solution, data flows.

3. Close co-ordination with SME's (Siemens, Rockwell, Mitsubishi, etc) to integrate & Qualify higher ended automation solutions

Technical Skills :

1. Knowledge of execution of high end solutions for automation having PLC/Network redundancy, Historians, Asset management, Thin client techniques, Virtualization on platforms like Siemens, Schneider etc

2. Design & develop 3rd party integration for process & handshake with third party equipment

3. Knowledge of techniques like batching logic (Batch Control) & LBSM

4. Knowledge of SDLC/STLC, documents/design phase & testing/execution phase

5. Good knowledge of 21 CFR, GAMP-5, ISA88. Knowledge of P&ID, PFDs FDS, VM

6. Evaluation and comparison of control panel BOM and help purchase team for vendor selection.

7. Evaluation and comparison of various instrumentation in process like sensors, transmitter, switch gears, etc

8. Preparing SOP for wiring termination of instruments for each project and guide site engineers during troubleshooting.

9. On site visit will be required for initial electrical and instruments termination and program startup.

10. Validation of PLC/ IPC / HMI will be part of job profile

11. Complete automation package documentation will be responsibility of automation engineer.

Accountable and Responsibility :

1. Comparing client requirement (URS) with TO & other design documents.

2. Finding & filing deviations observed in the above documents.

3. Attending kickoff meetings with client to create design basis of process philosophy

4. Reviewing control system design received from vendors, discuss with SME's & finalize prior to client submission

5. Reviewing final offer as per approved architecture, discuss on cost with vendor (for software efforts and required Hardware)

6. Discussion with client for domain related integrations, IT policies. Checking the compatibility for the same with system, discuss with SMEs for customization

7. Forecasting man-hours required for project execution, along with allocation, prioritizing & timelines for task (Project Planning)

8. Attend escalated site, interdepartmental, process issues.

9. Involved in vendor related R&Ds for customization & offer such solution to various customers as per their requirements.

10. Reviewing SOPs & ensuring release for QA approvals. Keep a track of final release in the system.

11. Ensuring Quality & Timely completion of domain related activities.

12. Suggesting quality improvements on the shortfalls encountered in previous project. Training team on customization implemented in each project, ensuring the new findings are recorded in the checklist & documents enabling an advancement in the upcoming projects

13. Vendor qualification with all the set parameters

Preferred Functional Skills :

1. Pharma or Bioprocess Equipment Mfg.

2. Good knowledge of GDP guidelines, AISME - BPE Standards

3. Customer Focused approach aligned with Organizational objectives

4. Travelling to site and factory will be 10 to 12 days per month.