Inviting Candidates for the role of “Process Engineer” in Engineering Department at Zydus Biologics, Biotech Park, Ahmedabad
Qualification: BE/B.Tech. Chemical Engineering or BE/ B.Tech Biotech
Candidate with 12-15 years’ experience in Process Engineering Design, Project & Engineering, Process Execution/ Commissioning & Qualification in Bio-Pharmaceutical (DS & DP).
Experience in Project completion in plant side as well as in consultancy for all design phases i.e. Concept Engineering, Basic Engineering & Detail Engineering. Knowledge of GMP aspects and regulatory requirements with rich experience of Validation & Qualification of Process Equipment & clean Utilities.
Should be conversant with Engineering Standards such as ASME-BPE; GMP Guidelines such as FDA, EUGMP, WHO, & ISPE baselines.
Candidate should have exposure/experience as mentioned below
1.Process side:
Process mapping/plant capacities estimation, Process Schedule planning, vendor document review of process equipment’s (Bioreactor, CGF, ACV, TFF, vessels P&ID, CQV doc),Process flow Diagram / Block Flow Diagram/ P&ID preparation and review, CIP/SIP cycle design and CIP time cycle calculations. (FDS review and writing)
2.Clean utility Side:
Clean Utilities (WFI/PUW/PS) Estimation, Design, WFI mapping (Tank sizing, flow rate, tank level & flow rate graph, Generation capacity), WFI & PUW various scheme design, Pure steam generation size calculation, P&ID design, execution.
3.Commissioning & qualification (CQV):
IQ, OQ preparation & reviews for process equipment’s like Process tank system, Autoclave, TFF system, Bioreactor system and other critical process & clean utility equipment Commissioning of Process & Utility equipment for Biopharma Facility (Insulin plant) like Chromatography systems, Centrifuge, TFF, WFI system, etc., functional Design Specification writing and validation of various process equipment like media/ buffer systems, process gases (02/N2/CO2), Homogenizer, TFF, Centrifuge etc.
Also, please note preference will be given to those who matches with above mentioned requirement and must have worked in Biotech, Vaccine & Injectable Pharma plants.
Interested candidates may send their updated CV along with current and expected CTC to [email protected] & mention subject line as “LinkedIn Process Engineer”