MSAT Engineer (Centrifugation)

No deviation; Singapore; On-site; SGD 75,000 - 95,000; Full time

Job summary

A leading pharmaceutical solutions company in Singapore is seeking an experienced MSAT Engineer (Centrifugation) to provide technical support for upstream manufacturing operations. The role encompasses routine MSAT assistance, expertise in upstream centrifugation processes, and involvement in the qualification and validation of new equipment. Candidates should have a bachelor's degree in Chemical Engineering and substantial experience in biopharmaceutical manufacturing. The position offers significant opportunities for professional development within an inclusive culture.

Benefits

Generous Leave Policy

Comprehensive Health & Wellness Coverage

Professional Development Opportunities

Inclusive Culture

Qualifications

• 5–8+ years of experience in biopharmaceutical manufacturing, MSAT, or upstream process engineering.
• Strong hands-on experience with upstream centrifugation in GMP environments.
• Familiarity with DQ, IQ, OQ, PQ, upstream process validation, and CPV.

Responsibilities

• Provide routine MSAT support for upstream manufacturing operations.
• Support qualification and validation of upstream centrifugation equipment.
• Prepare and approve GMP documentation related to MSAT processes.

Skills

Upstream centrifugation processes

Cell culture harvest

Deviation investigations

Technical guidance

Education

Bachelor’s degree in Chemical Engineering or related discipline

Tools

GMP documentation

Risk management frameworks

Job description

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

The MSAT Engineer (Centrifugation) provides technical MSAT support for routine upstream manufacturing operations, with a focus on cell culture harvest and clarification via centrifugation. The role also supports new and modified centrifugation equipment qualification and validation, ensuring robust upstream process performance, equipment readiness, and GMP compliance throughout the manufacturing lifecycle.

Key Responsibilities

Routine MSAT & Upstream Manufacturing Support

• Provide routine MSAT support for upstream manufacturing operations, particularly cell culture harvest and centrifugation steps.
• Support daily manufacturing by monitoring process performance, trending CPPs and CQAs related to harvest and clarification.
• Lead or support deviation investigations, root cause analysis, and CAPA implementation related to upstream centrifugation processes.
• Act as technical interface between Upstream Operations, QA, Engineering, and MSAT teams.

Centrifugation Process Expertise

• Provide subject matter expertise for upstream centrifugation processes, including disc‑stack and tubular bowl centrifuges used for cell harvest and clarification.
• Support definition, optimisation, and control of centrifugation parameters such as flow rate, g‑force/g‑speed, solids discharge frequency, feed characteristics (cell density, viability, viscosity).
• Troubleshoot centrifugation issues including poor clarification, cell lysis, yield loss, foaming, vibration alarms, and process variability.
• Support lifecycle management and continuous improvement of upstream centrifugation processes.

New Equipment Qualification & Validation

• Support qualification and validation of new or modified upstream centrifugation equipment, including disc‑stack centrifuges and associated automation/control systems.
• Support preparation, review, and execution of DQ, IQ, OQ, and PQ for centrifugation equipment.
• Perform equipment impact assessments and support risk assessments and change control activities.
• Collaborate with Engineering, Automation, and CQV teams to ensure centrifugation equipment is released for GMP use.

Process Validation & Lifecycle Management

• Support process validation and continued process verification (CPV) for upstream harvest and clarification processes.
• Support change management activities related to centrifugation process or equipment changes.
• Ensure alignment between upstream process capability, equipment capability, and regulatory expectations.

Documentation, Compliance & Regulatory Support

• Prepare, review, and approve GMP documentation, including process descriptions and flow diagrams, risk assessments (FMEA, HACCP), validation protocols and reports, deviation investigations and CAPAs, and change control documentation.
• Support internal audits and regulatory inspections by providing upstream MSAT technical input.
• Ensure all activities comply with GMP, GxP, and internal quality systems.

Cross‑Functional Collaboration & Knowledge Transfer

• Work closely with Upstream Manufacturing / Operations, Process Development, Quality Assurance, Engineering, Automation, and CQV teams.
• Provide technical guidance and training to operations teams on upstream centrifugation processes and equipment.
• Support knowledge transfer during equipment handover to operations.

Required Qualifications

• Bachelor’s degree or higher in Chemical Engineering, Biochemical Engineering, Biotechnology, or related discipline.
• 5–8+ years of experience in biopharmaceutical manufacturing, MSAT, or upstream process engineering.
• Strong hands‑on experience with upstream centrifugation / harvest processes in GMP environments.
• Experience supporting routine MSAT operations and equipment qualification/validation.
• Familiarity with DQ, IQ, OQ, PQ, upstream process validation, and CPV.
• Experience with deviation investigations, change control, and risk management.

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.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.