Biopharmaceutical/api Process Engineer

2 weeks ago

Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time

**Main Responsibilities**:

- Lead and execute improvement projects for biologics or API manufacturing processes, including facility modifications, equipment upgrades, and system implementations
- Provide specialized engineering expertise to manufacturing teams during new product introductions and technology transfers
- Coordinate cross-functional stakeholder collaboration to ensure alignment with business objectives and manufacturing requirements
- Support commissioning, qualification, and validation activities for new or modified equipment and systems
- Implement CAPA solutions identified through deviation investigations, regulatory inspections, or continuous improvement initiatives
- Support the change control process by providing technical assessments, impact analyses, and implementation strategies for proposed changes
- Assist with process scale-up efforts from development to commercial manufacturing
- Review and approve engineering designs, functional specifications, and validation protocols
- Lead root cause analysis (RCA) activities for complex process or equipment issues
- Provide technical input for risk assessments and change controls related to manufacturing processes and systems
- Evaluate new technologies and equipment for potential implementation in manufacturing operations
- Develop engineering documentation including user requirements, functional specifications, and design documents
- Ensure all engineering activities comply with cGMP, regulatory requirements, and company policies
- Support regulatory submissions and inspections with technical expertise
- Author standard operating procedure, technical reports and present project outcomes to stakeholders and management

**About You**:

- Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field; Master’s degree preferred
- Minimum of 3-6 years of experience in biologics manufacturing, API manufacturing or process engineering roles
- Experience in either upstream cell culture processes (seed train, bioreactor operations) and/or downstream purification processes (filtration, chromatography), API manufacturing processes
- Experience working in GMP manufacturing facilities and understanding of clean room environments
- Experience in handling manufacturing systems such as DeltaV, PLC, MES, SCADA, HMI
- Strong understanding of biopharmaceutical or API manufacturing processes and equipment
- Knowledge of process control systems and automation in biologics manufacturing
- Proficiency in risk assessment methodologies and change management
- Understanding of regulatory requirements for biologics or API manufacturing and facility modification

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