Pharmaceutical Engineer, Hot Melt Extrusion

  • Location

    Singapore

  • Sector:

    Engineering & Manufacturing

  • Job type:

    Permanent

  • Salary:

    S$6000 - S$7500 per month

  • Contact:

    Abhik Damani

  • Contact email:

    abhik.damani@voltasia.com.sg

  • Job ref:

    BBBH8977_1614924204

  • Published:

    2 months ago

  • Expiry date:

    2021-04-04

  • Consultant:

    #

My client is a global biopharmaceutical company committed to developing innovative pharmaceutical technologies. To cater to a global expansion, a new Production Engineer (Hot Melt Extrusion) has been created

This role will be reporting to the R&D Director and will be the main subject matter expert for developing a hot melt extrusion process to produce designated implants

Responsibilities:

  • Develop a hot melt implant manufacturing process and produce implants that consistently meet designated performance criteria
  • Ensure appropriate Identification and documentation of critical process parameters
  • Implement IQ/OQ/PQ
  • Produce a manufacturing method capable of method transfer to new facilities
  • Ensure production method(s) comply with relevant regulatory requirements
  • Prepare SOPs for use by production operators
  • Liaise with Engineering, R&D, Scientific Affairs, QA, and RA
  • Effectively manage equipment vendors, consumables vendors, and suppliers
  • Train production operators in the SOPs

Requirements:

  • Advanced Degree in Engineering/Material Science/Polymer Chemistry or equivalent
  • At least 3 years' experience in hot melt extrusion, preferable in the pharmaceutical industry
  • Strong working knowledge of GMP, process development and validation
  • Technical writing skills, especially in standard operating procedures
  • Strong knowledge in pharmaceutical quality systems
  • Experience in product technology transfer
  • Training and experience in product quality management
  • Ability to complete tasks with speed and accuracy
  • Strong problem-solving skills

Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).