Sr. Engineer - Process & Regulatory

/ Responsibilities

1. Preparation of PFD, URS, FDS, Cycle Time Analysis etc.
2. Calculation for Utilities, Peak Loads, Pipe/Pump sizing, Equipment capacity, and other accessories capacity/load/size
3. Preparation of PID, TS, DS, BOQ, Tender, Validation documents (VMP, FAT, IQ, OQ, PQ etc)
4. Equipment/Instrument Selection, Vendor Evaluation, Techno-commercial Report Preparation
5. Site execution of validation activities

Desired Skills

Basic Requirements:

1. Knowledge of chemical engineering unit operations/processes
2. Knowledge of chemical engineering design calculations
3. Knowledge of API Pharmaceutical Processing
4. Knowledge of AutoCAD (Preferred)
5. Knowledge of various Regulatory / GMP / Statutory requirements related to Pharmaceuticals Biotech manufacturing (Preferred)
6. Knowledge of engineering guidelines like ISPE, ASME, ASME-BPE, ASTM etc

Skills:

1. Hands on experience in Basic and Detailed Engineering for Pharmaceutical API facility
2. Experience in Preparation Heat Mass Balance calculation, PFD PID.
3. Experience in sizing of equipment s/ Preparation of data sheet for all equipment s such as Reactors, condenser, columns pumps, agitators, tanks, scrubber etc.
4. Provide Process data for all instruments and interlocking descriptions.
5. Preparation of Hydraulic calculation for pumps, pipeline.
6. Carrying out Hazop study.
7. Calculation of Clean and general utility consumptions.
8. Lead the engineering team with respect to process requirement.
9. Co-ordination with other departments (3D Mechanical, HVAC, Civil, Electrical)
10. Preparation of Technical bid evaluation.

Qualification

• Bachelors Chemical, Mechanical, Pharmacy Biotech
• Process / Design Engineer from Consulting Engineering (Pharmaceuticals) Companies- Preferred
• Process Engineer / Project Engineer from Finished Pharmaceuticals (API, Injectable plant)
• Design Engineer from Equipment Manufacturing Companies

Relevant Experience

07 to 10 Years of relevant experience in Pharmaceutical/API projects

Location

Thane