Technical Specialist (Manufacturing Operations)

No deviation; Singapore; On-site; SGD 90,000 - 130,000; Full time

Benefits offered by this job

Generous Leave Policy

Health & Wellness Coverage

Professional Development Opportunities

Inclusive Culture

Job summary

No deviation is seeking a Technical Specialist, Manufacturing Operations in Singapore to support GMP manufacturing across readiness, run, and release phases.

You will collaborate with Manufacturing, Quality, MSAT, Engineering, and Supply Chain teams to ensure regulatory compliance, operational excellence, and timely product delivery while leading investigations and CAPA activities in a fast-paced environment.

Qualifications

• Minimum 3–8 years in GMP pharma/biotech manufacturing environments.
• Hands-on experience with deviation investigations, CAPA, and change control.
• Experience supporting technology transfers and manufacturing campaigns is preferred.

Responsibilities

• Developing, reviewing, and revising Master Batch Records (MBRs).
• Preparing and managing Change Requests (CRs) and associated documentation.
• Creating, updating GMP documentation, procedures, and work instructions.
• Facilitating and supporting operational risk assessments.
• Coordinating and delivering pre-campaign training activities.
• Ensuring manufacturing processes, documents, and systems are ready prior to campaign execution.
• Supporting cross-functional teams in readiness reviews and manufacturing preparations.
• Assessing and managing manufacturing deviations through the Deviation Review Board (DRB) process.
• Leading and tracking Corrective and Preventive Actions (CAPAs).
• Managing assigned tasks, action items, and compliance commitments.
• Supporting CSCC investigations and issue resolution.
• Managing rejected materials and associated investigations.
• Participating in internal and external audits related to manufacturing operations and investigations.
• Collaborating with Manufacturing, Quality, Engineering, and MSAT teams to resolve process-related issues.
• Monitoring operational trends and identifying opportunities for continuous improvement.
• Leading deviation investigations and trend investigations.
• Performing comprehensive root cause analysis (RCA).
• Conducting product impact assessments to support batch disposition decisions.
• Identifying, implementing, and verifying CAPA effectiveness.
• Preparing clear, concise, and technically sound investigation reports.
• Supporting timely lot disposition and product release activities.
• Ensuring compliance with GMP requirements and internal quality systems.

Skills

Deviation investigations

CAPA management

Change control processes

Technology transfer support

Cross-functional collaboration

Education

Bachelor's Degree in Biotechnology or related field

Job description

Position Overview

The Technical Specialist, Manufacturing Operations is responsible for providing technical and operational support across the manufacturing lifecycle, encompassing Operational Readiness, Operational Run, and Operational Release activities. This role plays a critical part in ensuring compliant, efficient, and uninterrupted GMP manufacturing operations through technology transfer support, deviation management, CAPA implementation, investigation leadership, and batch disposition support.

The successful candidate will collaborate closely with Manufacturing, Quality, MSAT, Engineering, and Supply Chain teams to ensure operational excellence, regulatory compliance, and timely product delivery.

Key Responsibilities

1. Operational Readiness

• Developing, reviewing, and revising Master Batch Records (MBRs).
• Preparing and managing Change Requests (CRs) and associated documentation.
• Creating, updating, and maintaining GMP documentation, procedures, and work instructions.
• Facilitating and supporting operational risk assessments.
• Coordinating and delivering pre-campaign training activities.
• Ensuring manufacturing processes, documents, and systems are ready prior to campaign execution.
• Supporting cross-functional teams in readiness reviews and manufacturing preparations.

2. Operational Run

• Assessing and managing manufacturing deviations through the Deviation Review Board (DRB) process.
• Leading and tracking Corrective and Preventive Actions (CAPAs).
• Managing assigned tasks, action items, and compliance commitments.
• Supporting CSCC investigations and issue resolution.
• Managing rejected materials and associated investigations.
• Participating in internal and external audits related to manufacturing operations and investigations.
• Collaborating with Manufacturing, Quality, Engineering, and MSAT teams to resolve process-related issues.
• Monitoring operational trends and identifying opportunities for continuous improvement.

3. Operational Release

• Leading deviation investigations and trend investigations.
• Performing comprehensive root cause analysis (RCA).
• Conducting product impact assessments to support batch disposition decisions.
• Identifying, implementing, and verifying CAPA effectiveness.
• Preparing clear, concise, and technically sound investigation reports.
• Supporting timely lot disposition and product release activities.
• Ensuring compliance with GMP requirements and internal quality systems.

Required Qualifications

• Bachelor's Degree in Biotechnology, Life Sciences, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or a related discipline.
• Minimum 3-8 years of experience in GMP pharmaceutical, biotechnology, biologics, vaccine, or cell therapy manufacturing environments.
• Experience supporting manufacturing operations, quality systems, or technical operations.
• Hands-on experience with deviation investigations, CAPA management, and change control processes.
• Experience supporting technology transfers and manufacturing campaigns is preferred.
• Familiarity with batch release processes and product disposition activities is advantageous.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.