Technical Specialist (Manufacturing Operations)

No deviation Pte Ltd; Singapore; On-site; SGD 70,000 - 110,000; Full time

Benefits offered by this job

Generous leave

Health & dental coverage

Professional development

Inclusive culture

Career impact

Job summary

No deviation Pte Ltd is seeking a Technical Specialist, Manufacturing Operations to provide technical and regulatory compliant support across the manufacturing lifecycle in Singapore. You will partner with Manufacturing, Quality, MSAT, Engineering and Supply Chain to ensure readiness, run campaigns, and support timely product release in a GMP environment.

The role emphasizes deviation investigations, CAPA management, change control and technology transfer support, with opportunities to lead

Qualifications

• Bachelor's degree in Biotechnology, Life Sciences, Biochemical/Chemical Engineering, Pharmaceutical Sciences, Microbiology or related field.
• 3-8 years of GMP pharmaceutical/biotech manufacturing experience.
• Experience supporting manufacturing operations, quality systems, or technical operations.

Responsibilities

• Operational Readiness: support technology transfers, new product introductions, and campaigns; develop and manage MBRs; process CRs and GMP docs; support risk assessments and pre-campaign training.
• Operational Run: manage deviations via DRB; lead CAPAs; track tasks and compliance commitments; assist investigations and materials disposition; participate in internal/external audits; drive cross-functional issue resolution.
• Operational Release: lead deviation and trend investigations; perform root cause analyses; support batch disposition; verify CAPA effectiveness; ensure GMP compliance and timely product release.

Education

Bachelor's degree, related field

3-8 years GMP experience

Deviation investigations

CAPA management

Change control

Technology transfers

Manufacturing campaigns

Quality systems

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

   Support manufacturing readiness activities for technology transfers, new product introductions, and process campaigns by:

   • 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

   Provide technical support during manufacturing campaigns by:

   • 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

   Support product release activities through investigation and quality review by:

   • 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.