Process Lead Engineer
No deviation · Singapore · On-site
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About No deviation
At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.
Position Overview
We are seeking an experienced Process Lead Engineer to provide technical leadership and process engineering support for pharmaceutical manufacturing operations.The role will have particular ownership of CIP, SIP, washers and autoclaves , while supporting process design, equipment qualification, troubleshooting, continuous improvement and automation-related activities. The successful candidate will act as a key technical interface between Manufacturing Science & Technology (MS&T), Engineering, Automation and Operations to ensure reliable and compliant manufacturing operations.
Key Responsibilities
Process Engineering & Equipment Ownership
Provide technical ownership and engineering support for CIP, SIP, washers, autoclaves and associated process systems .
Develop and maintain process engineering documentation throughout the equipment and process lifecycle.
Support process and equipment design activities, including: P&ID development and review
User Requirements Specifications (URS)
System Risk Assessments (SRA)
Functional Risk Assessments (FRA)
Design Reviews / Design Qualification
HAZOP and other process risk assessments
Provide technical support for equipment and process modifications, upgrades and improvement initiatives.
Qualification & Validation
Support FAT, SAT, commissioning, IQ, OQ, PQ, qualification, requalification and validation activities.
Provide process engineering input during equipment qualification and ensure systems meet operational and process requirements.
Support investigation and resolution of qualification-related issues and deficiencies.
Process Improvement & Troubleshooting
Lead engineering-related continuous improvement initiatives to improve: Process reliability
Equipment performance
Yield
Cycle time
Operational efficiency
Lead complex process and engineering troubleshooting beyond frontline operational troubleshooting.
Develop and implement solutions to minimise manufacturing and supply risks.
Drive optimisation of processes such as CIP/SIP cycles and equipment operating parameters .
Provide independent technical support to ensure smooth day-to-day site operations.
Automation & MS&T Interface
Act as a key technical bridge between MS&T and Automation .
Translate process requirements into appropriate automation…