Senior Manufacturing Process Specialist - GMP & CI

AbbVie Inc.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

AbbVie is seeking a seasoned professional to manage technical documentation and drive continuous improvement in a biologics manufacturing context in Singapore. You will investigate non-conformances, implement CAPAs, and collaborate with Operations and quality to ensure GMP compliance.

The role includes developing training modules, managing change control, and supporting regulatory inspections, with emphasis on data integrity and effective communication across cross-functional teams.

Qualifications

• Master or degree with 5–7 years in Biologics Production or equivalent.
• Good working knowledge of cGMP and regulatory requirements for manufacturing.
• Experience with GMP systems such as Trackwise, SAP, LIMS, MES preferred.
• Experience with regulatory inspections is required.

Responsibilities

• Perform technical writing and investigate non-conformances with Operations and cross-functional teams.
• Develop and implement corrective and preventive actions with Operations.
• Lead change processes to enhance operations and document updates.
• Create and conduct training modules for Operations and new hires.
• Analyze KPIs and optimize workflows; manage electronic batch records.
• Support regulatory inspections and internal audits; engage in improvement projects.
• Organize regular cross-functional meetings to discuss daily operations.

Skills

Technical writing

GMP compliance

Change management

Cross-functional lead

Gemba walkdowns

Regulatory inspections

Quality systems

Trackwise

LIMS

SAP

Education

Master's or degree (Biologics/related)

Tools

Trackwise

LIMS

SAP

POMSnet

Delta-V

MES systems

Job description

AbbVie is seeking a seasoned professional to manage technical documentation and drive continuous improvement in a biologics manufacturing context in Singapore. You will investigate non-conformances, implement CAPAs, and collaborate with Operations and quality to ensure GMP compliance.

The role includes developing training modules, managing change control, and supporting regulatory inspections, with emphasis on data integrity and effective communication across cross-functional teams.