At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.
About the Function:
Projects & Engineering function manages capital investments for expansion of DS and DP manufacturing facilities globally that are either greenfield or brownfield. With a team of about 50 and split into various verticals including Process Engineering, Automation and Instrumentation, Electrical, Mechanical, Project Management, Commercial, Civil, and Site execution.
Process Engineer will serve as technical resource in equipment/ facility design meeting User Requirement Specifications. Reporting to the Process Engineering Lead, he/she will work across various organizational functions including Operations, Quality, MSAT and, external consultants and vendors to help ensure design, quality and qualification timelines meet Business Objectives.
About the Role:
- Expertise in managing the design for Upstream, Downstream equipment (Drug Substance) and Drug product filling equipment.
- Manage the design (lifecycle- URS to site qualification) for Process Equipment like Bioreactors, Fermenters, Continuous centrifuges, Chromatography systems, TFF, Filling systems, Buffer and Media Tanks, Filling Line, Isolators, Autoclave, Parts washer, Formulation vessels, lyophilizer, Visual Inspection machine, Clean Utility Generation…
- Act as a Subject matter expert through Best Practice networks (BPNs) and/or working groups to deliver technology strategy.
- Understanding business case and develop concept proposal.
- Preparation of process flow sheet, capacity, facility and equipment layouts, utility compilation, concept/ technical documentation, and budget proposals.
- Aware of technology process trends and benchmarks in the industry. Benchmark against global standards and in compliance with regulatory standards.
- Aware of process automation, system architecture
- Manage external consultants, Internal stakeholders, to deliver projects in a timely manner, meeting design and quality requirements.
- Good communication and interpersonal and troubleshooting/ problem solving skills.
- Ability to navigate diverse organizational landscapes with dynamic blend of technical acumen and leadership capabilities.
- Adherence to safety, Health, and Environment measures
- Experience:
4 to 10 yaers