Lead Engineer (Pharma/Process)

NOVEXX PTE. LTD.; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

NOVEXX PTE. LTD. is seeking an experienced Process Engineer to lead design, validation, and qualification activities for pharmaceutical processing systems in Singapore.

You will manage documentation, CAPAs, and deviations while driving improvements in yield, cycle-time, and automation. The role includes on-call support and collaboration with MS&T and Automation teams. Responsibilities include ownership of SIP/CIP, Washer and Autoclave systems, plus support for FAT/SAT and IQ/OQ/PQ activities to

Qualifications

• Experience in process engineering design and validation in a manufacturing setting.
• Ability to manage documentation, change controls, deviations, and CAPAs.
• Familiarity with SIP/CIP systems and sterilization equipment.

Responsibilities

• Lead process engineering design, P&ID, URS, risk assessments, HAZOP, and qualification activities.
• Manage engineering documentation, Change Controls, Deviations, and CAPAs.
• Own SIP, CIP, Washer, and Autoclave systems.
• Support FAT/SAT, IQ/OQ/PQ, validation, and requalification.
• Drive process improvements, yield/cycle-time optimization, and automation changes.
• Provide technical troubleshooting and 24/10 on-call support to ensure smooth operations.
• Bridge MS&T and Automation requirements, including recipe development and testing.
• Provide technical solutions and lead engineering activities to minimize operational and supply risks.

Skills

Process engineering

P&ID

URS

HAZOP

Change controls

CAPAs

SIP

CIP

Autoclave

Washer

FAT/SAT

IQ/OQ/PQ

Validation

Automation

Troubleshooting

On-call support

Recipe development

Job description

Key Responsibilities

• Lead process engineering design, P&ID, URS, risk assessments, HAZOP, and qualification activities.
• Manage engineering documentation, Change Controls, Deviations, and CAPAs.
• Own SIP, CIP, Washer, and Autoclave systems.
• Support FAT/SAT, IQ/OQ/PQ, validation, and requalification.
• Drive process improvements, yield/cycle-time optimization, and automation changes.
• Provide technical troubleshooting and 24/10 on-call support to ensure smooth operations.
• Bridge MS&T and Automation requirements, including recipe development and testing.
• Provide technical solutions and lead engineering activities to minimize operational and supply risks.