Senior Engineer - Process & Regulatory (4-6 yrs)
Apply at / call 9711918654
Sr. Engineer / TL - Process & Regulatory
Job Description / Responsibilities
1. Preparation of PFD, URS, FDS, Cycle Time Analysis etc.
2. Process Equipment Sizing.
3. Calculation for Utilities, Peak Loads, Pipe/Pump sizing, Utility Equipment capacity, and other accessories capacity/load/size
4. Preparation of P&ID, TS, DS, BOQ, Tender, Validation documents (VMP, FAT, IQ, OQ, PQ etc)
5. Equipment/Instrument Selection, Vendor Evaluation, Techno-commercial Report Preparation
6. Site execution of validation activities
Basic requirement:
1. Knowledge of Pharmaceutical processes / operations.
2. Knowledge of chemical engineering design calculations
3. Knowledge of AutoCAD (Preferred)
4. Knowledge of various Regulatory / GMP / Statutory requirements related to Pharmaceuticals & Biotech manufacturing (Preferred)
5. Knowledge of engineering guidelines like ISPE, ASME, ASME-BPE, ASTM etc
Skills:
1. Technically strong (fluid dynamics, Heat & Mass Transfer etc.)
2. Good in literature survey from internet - Process, Processing Machines & components, etc.
3. Understanding of Process Planning, scheduling, Gantt chart preparation
4. Basic Understanding of SIP/CIP, GMP, Water for Pharmaceutical Use, Equipment Qualification (Validation), Contamination & Cross-Contamination etc.
5. Strong written communication skill (mandatory).
Qualification
- BE - Chemical / Biochemical/ Biotechnology / Mechanical
Relevant Experience
- 6 - 8 Years of relevant experience in Pharma - OSD and Injectable and Biotech Projects
- Process / Design Engineer from Consulting & Engineering (Pharmaceuticals/Biotech) Companies- Preferred
