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Biosimilar Projects

4 weeks ago

Bengaluru, Karnataka, India Biocon Biologics Full time
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.

Mechanical lead will serve as technical resource in facility and utility design meeting User Requirement Specifications. Reporting to the Design Lead, he/she will work across various organizational functions including Operations, Quality and, external consultants and vendors to help ensure design, quality and qualification timelines meet Business Objectives.

About the Role:
Act as a Subject Matter Expert in HVAC, Clean and black utilities, Cleanrooms, process and utility piping, fire fighting systems, warehousing, and material handling.
Manage the design (lifecycle- URS to site qualification) for Utility Equipment like Air Handling Unit, Air Compressor, Cooling tower, Chilled water and glycol systems and distribution, Gas generation and distribution, Plant Steam generation and distribution, condensate recovery systems, Water pretreatment, WFI and purified water storage distribution, pure steam distribution, warehouse racking and material handling systems, Cleanroom panel and furniture including LAF's and pass boxes.
Strategic planning: Establish concept/ basic and detail engineering reports for designated projects.
Manage design and execution in collaboration with external consultants, Internal stakeholders, to deliver projects in a timely manner, meeting design and quality requirements.
Preparation of process flow sheet, capacity, facility and equipment layouts, utility compilation, concept/ technical documentation, scheduling, and budget proposals.
Aware of Bioprocess manufacturing processes and process automation.
People manager- effectively lead and coach direct reports
Aware of technology process trends and benchmarks in the industry. Benchmark against global standards and in compliance with regulatory standards.
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 and provide sustainable solutions.

Qualification Required:

Degree:

BE/B.Tech/ME/M.Tech/
Course:

Chemical/Mechanical
Experience:

10+ years in Pharma/Biopharma/Biologics manufacturing