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 (COV):
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10,00 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/C02), Homogenizer, TFF, Centrifuge etc.
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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 neha.v.patel@zyduslife.com & mention subject line as "Linkedin - Process Engineer"