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Our client is an Indian biopharmaceutical company based in Bangalore, India ,The Company manufactures generic active pharmaceutical ingredients (APIs) that are sold across the globe, it also manufactures novel biologics, as well as, biosimilar insulins and antibodies, which are sold in India as branded formulations.
ROLE RESPONSIBILITIES
Provide design leadership and lead the customer interface activities for the various sites doing large scale Mammalian and Microbial based Drug Substance facilities in compliance with international regulations like USFDA and EMEA.
Of total experience, significant percentage more than 50% need to be in designing process and facility of above mentioned domain.
Preferred, to provide design leadership in Fill Finish facilities for Vials, PFS and Cartridges. Exposure in handling facilities with Isolator will be added advantage.
Preferred, providing design leadership devices related to large and small molecule.
Hands on experience in design of disciplines other than process like CSA, Mechanical, Electrical, HVAC, Automation and Clean/Black Utilities.
Should be versed with latest cGMP/ISPE/ASME BPE/GAMP/CFR Part 11 guidelines.
Apply new and innovative and untried approaches to achieve targeted performance and results.
Work with variety of people and cultures to achieve targeted performance and results.
Communicate across the organization, foster exchange information and best practises.
Responsibility would be heading the bio process design team, and leading from conceptual design to basic/detail engineering and then to handover after commissioning & qualification.
Proven Technical expertise in CAPEX and Design Management in Green field and Brownfield Biotech set up with in India and overseas.
Strong stakeholder orientation and must have prior experience of being functional representative for the defined group. Will be responsible for managing internal stakeholders like User/QA group and external stakeholders like Design consultant/Vendors.
Must have prior experience of leading a continues improvement in various aspects of projects which has led to productivity enhancement.
Min requirement of Education being B Tech from Premier Institute like IIT, UDCT and NIT.
BASIC QUALIFICATION
Bachelor degree in Engineering, Master Degree in Engineering is preferred. From reputed College/University from Tier 1 Institution – IIT, UDCT, NIT
Min 15 years of in Design, Construction and Commissioning of Pharmaceutical facilities in Biotech and Packaging areas and well versed with cGMP requirements associated with these facilities.