Job Description

Department Details

Role Summary

Degree in Bio-process/Chemical Engineering (B.Tech/M.Tech/M.Chem) or equivalent from Premier
Institute

• More than 4-10 years 'of experience in GMP sites relevant to the specialist area of expertise.
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• Minimum of 4-10 years of Capital projects experience
• Strong communication, influencing and coaching skills
• Broad interdisciplinary technical knowledge
• Broad knowledge of process innovation and best practice in field of expertise
• Proven project discipline knowledge on executing major capital projects.
• Experience in the Projects and execution environment
• In depth knowledge of Bio-pharmaceutical processes (Upstream and downstream)
• Experienced in working with internal and external project groups / vendors and leading them
• Ability to challenge projects and/or technical solutions
• Used to working in a complex global / matrix organization

Key Responsibilities

• Own and develop Biologics Upstream and downstream production equipment design and selection criteria to support all capital investments with specific emphasis on design, standards and cost.
• Lead new biologics facility design to implement process standards understanding business case, compliance and complexity of implementation.
• Responsible to design Single use and Multi-use (Stainless Steel) bioreactor facility and downstream equipment design includes Centrifuge, Chromatography systems and final purification systems
• Participate as subject matter experts through Best Practice networks (BPNs) and/or working groups to deliver technology strategy, commonality in solution selection, standards and trouble shooting.
• Develop & prepare the capex, facilitate approval and implement the solution.
• Preparation of Process flow sheet, process scheduling and equipment layout.
• Aware of technology process trends and benchmarks in the industry. Benchmark against global standards and in compliance with regulatory standards (FDA, EMEA etc)
• Ensure compliance to all regulatory GMP, Safety and Environmental requirements.
• Manage contractors and external vendors to deliver robust technical solutions.
• Lead the Equipment FAT, Installation, SAT, IQ, OQ and support PQ.

Educational Qualifications

Required Education Qualification: B.E
Required Experience: 4 - 8 years