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Engineer, Validation Engineer

Job in Indiana, Indiana County, Pennsylvania, 15705, USA
Listing for: IOL Chemicals And Pharmaceuticals Limited
Full Time, Contract position
Listed on 2025-12-15
Job specializations:
  • Engineering
    Validation Engineer, Quality Engineering, Process Engineer, Biotechnology
Job Description & How to Apply Below
Location: Indiana

IOL CHEMICALS AND PHARMACEUTICALS LIMITED

DEPARTMENT :

Research & Development SUB- DEPTT :

R & D

JOB TYPE :

Full time / Contract Job Req  :863

Job Summary

The Process Validation and Technology Transfer Specialist will oversee the transfer of new processes from R&D to Kilo Lab and Plant validation. This role involves preparing engineering design packages, ensuring the fitment of new products in existing facilities, improving solvent recovery processes, and executing validation batches. The specialist will also compile and analyze process data, assist in scale-up studies, and maintain all critical process parameters during validation activities.

Key Responsibilities
  • Oversee the technology transfer of new processes from R&D to Kilo Lab and Plant validation.
  • Prepare Basic Engineering design packages, including PFD, Heat and material balance, Utility/Process equipment & instrument database, Equipment Sizing, and Line size calculations.
Qualifications
  • Bachelor's or Master's degree in Chemical Engineering, Process Engineering, or a related field.
  • Proven experience in process validation and technology transfer.
  • Strong understanding of engineering design packages and process equipment.
  • Excellent analytical and problem-solving skills.
  • Ability to work collaboratively with cross-functional teams.
  • Strong attention to detail and ability to maintain accurate records.
  • Good communication and organizational skills.
  • Ensure the fitment of new products in existing manufacturing facilities and check equipment suitability for pilot scale.
  • Improve solvent recovery processes and execute them in validation batches.
  • Demonstrate R&D validation batches and compile observations for scale-up studies.
  • Assist in executing validation plans for pilot plant and commercial scale.
  • Ensure all critical process parameters are maintained and controlled during validation activities.
  • Assist in smooth scale-up studies in Kilo Lab and compile process data generated from scale-up batches.
  • Compile process data generated during lab validation, scale-up studies, and plant validations.
  • Make all necessary modifications and preparations before starting validation.
  • Review BPCR from Plant and Optimization reports.
  • Monitor and take precise observations of optimization and validation batches.
  • Compile validation batch data with analytical reports.
  • Plan with cross-functional teams for better execution of validation batches.
  • Assist the immediate reporting manager in completing tasks assigned by the organization.
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