Process Engineer

2 weeks ago

Singapore ANTER CONSULTING PTE. LTD. Full time

**About the Role**:
**Key Responsibilities**:

- Lead and manage deviation investigations, identify root causes, and implement effective corrective and preventive actions (CAPAs).
- Develop and execute cleaning validation strategies for CIP, SIP, and manual cleaning processes in compliance with site and regulatory standards.
- Support or lead technology transfer activities for new products, including process mapping, risk assessments, documentation, and on-floor support.
- Drive continuous improvement by analysing process data and identifying opportunities for optimisation in yield, cycle time, and equipment reliability.
- Author, review, and maintain key GMP documentation including batch records, SOPs, risk assessments, and validation protocols.
- Collaborate with cross-functional teams (QA, Manufacturing, Engineering, Validation) to support daily operations and project delivery.
- Contribute to change control initiatives related to process or equipment enhancements.
- Support troubleshooting of process equipment and investigations of process performance issues.

**Requirements**:

- Bachelor’s Degree in Chemical Engineering, Biochemical Engineering, or a related field.
- Minimum 5 years of experience in a GMP pharmaceutical or biopharmaceutical manufacturing environment.
- Proven track record in deviation investigation, cleaning validation, and tech transfer.
- Strong understanding of cGMP, ICH, and industry best practices in pharmaceutical manufacturing.
- Experience with batch manufacturing, CIP/SIP systems, and cross-functional coordination.
- Excellent analytical, communication, and technical writing skills.
- Able to manage multiple priorities and work effectively in a dynamic, fast-paced environment.

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