Job Title : Process Engineering Consultant – Biopharmaceutical Manufacturing
Location : Singapore
EFOR Consulting is seeking an experienced Process Engineering Consultant to support leading pharmaceutical and biopharmaceutical clients in Singapore. If you are passionate about optimizing manufacturing processes, implementing the latest bioprocess technologies, and driving operational excellence in a GMP environment, we’d like to hear from you !
Key Responsibilities :
- Process Documentation & Review: Support the creation, review, and optimization of Standard Operating Procedures (SOPs), manufacturing procedures, and process recipes to ensure best practices and regulatory compliance.
- Single-Use Technologies: Provide subject matter expertise on the implementation, operation, and troubleshooting of single-use bioprocessing systems and equipment.
- New Product Introduction (NPI): Support technology transfer and NPI activities, including process validation, change management, and manufacturing readiness.
- Cleaning Validation: Lead or support cleaning validation efforts, including protocol development, execution, and report generation in compliance with GMP standards.
- Batch Record & MES Management: Review and optimize batch records and Master Electronic Batch Records (MES), ensuring data integrity and alignment with process needs.
- Contamination Control: Advise and support on contamination control strategy implementation across aseptic and non-sterile manufacturing, with a strong understanding of regulated cleanroom environments.
Your Profile :
- Degree in Engineering, Biotechnology, Pharmacy, or related life sciences field.
- Proven hands-on experience in process engineering within pharmaceutical or biopharma manufacturing environments.
- Demonstrated expertise with single-use systems for upstream and/or downstream processing.
- Strong background in SOP writing, batch records, and MES management.
- Successful participation in New Product Introduction projects and cleaning validation activities.
- In-depth understanding of contamination control and aseptic manufacturing practices.
- Excellent communication and documentation skills; problem-solving attitude.
- Experience in a consulting or client-facing role is an advantage.