Hyde EC Job - 40025484 | CareerArc
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Company: Hyde EC
Location: Hyderabad, Telangana, India
Career Level: Mid-Senior Level
Industries: Business Services, Consulting

Description

Role: Process engineer – Biotech/ API pharma / Fill Finish (Senior/ Mid-level)

Key Responsibilities
 

  • Assist the Lead Process Engineer with conceptual design deliverables such as Process Flow Diagrams, Material and Energy Balances. 
  • Acts as a drug product technical expert to provide solutions when troubleshooting issues in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection, and transportation, for parenteral products. 
  • Design utilities generation and distribution systems for new and existing manufacturing processes, including Utility Sizing models. 

  • Generate Process P&IDs that include, process control strategy and CIP/SIP functions, if appropriate. Also, generate P&IDs for critical utility systems, such as Pharma Water systems, Clean Steam, Process Gases, Heat Transfer Systems and Process Waste. 

  • Perform engineering studies for expanding, improving or automating existing facilities without supervision. 

  • Generate/review Equipment specifications and Equipment Datasheets for process equipment and instrumentation. 

  • Support the delivery of Vendor packages through Scoping, Specification, Detailed Design, Construction and CQV. 

  • Generate Process Calculations to support design. 

  • Support Process Safety and Environmental studies including HAZOP, Risk Assessment. 

  • Ensures completion and turnover of all project origination design development, and ETOP documentation. 

Skills and experience required: 

  • Minimum of 4-10 years of process engineering design experience. 
  • ??????8 + years of experience in support of Drug Product (DP) processing in specific areas such as Sterile Processing, Tech Transfer or Validation. 
  • Process design and operations experience in pharmaceutical facilities, which include biologic and/or organic synthesis Active Pharmaceutical Ingredients. 

  • Bachelor's or master's degree in Chemical / Biochemical Engineering (or equivalent education). 

  • At least 4 years of experience in a GMP or highly regulated engineering environment including upstream and downstream biopharmaceutical facility design, troubleshooting, start-up and commissioning at a senior level working with clients, vendors and other design engineers to execute projects for biotech and pharmaceutical clients is  an advantage. 

  • General knowledge of Pharma system design and applicable codes in process engineering. 

  • Has demonstrated strong time management skills and the ability to manage projects, problem solve and communicate effectively with co-workers. 

  • Good interpersonal and communication skills.  

  • Willing to travel for project durations. 

  • Takes ownership of assignments, can work both independently and as part of the team. 

  • Ability to work in a fast paced and challenging environment. 

  • Excellent organization skills with the ability to manage multiple tasks simultaneously. 

  • Must be able to manage and lead people effectively.

     #LI-HM1


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