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).