MSAT Engineer (UF/DF)

No deviation; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical company in Singapore is seeking an experienced MSAT Engineer specialized in downstream processing, particularly ultrafiltration and diafiltration. The role involves supporting routine operations, validating new equipment, and ensuring compliance with GMP regulations. Candidates should have at least 8 years of experience in biopharmaceutical manufacturing, with strong hands-on expertise in downstream processes. Join a team that values innovation and contributes significantly to the pharmaceutical industry.

Benefits

Generous Leave Policy

Comprehensive Health & Wellness Coverage

Professional Development Opportunities

Inclusive Culture

Qualifications

• 8-10+ years of experience in biopharmaceutical manufacturing and MSAT.
• Strong hands-on experience in downstream processing.
• Proven experience supporting routine MSAT operations.

Responsibilities

• Provide UF/DF subject matter expertise in biopharmaceutical manufacturing.
• Support qualification of new or modified downstream process equipment.
• Ensure compliance with GMP and GxP regulations.
• Prepare and approve GMP documentation.

Skills

Downstream processing

Ultrafiltration (UF)

Diafiltration (DF)

Risk management

Validation protocols

Education

Bachelor's degree in Chemical Engineering

Higher degree in Biochemical Engineering or Biotechnology

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, spleen 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 (Downstream / Ultrafiltration) supports routine downstream manufacturing operations while also providing MSAT technical support for new and modified equipment qualification and validation. The role ensures process robustness, equipment readiness, and ongoing compliance throughout the manufacturing lifecycle in a GMP biopharmaceutical environment.

Key Responsibilities

Ultrafiltration / Diafiltration (UF/DF) Expertise:

• Provide subject matter expertise for UF/DF processes, including TFF systems, membranes, and single-use assemblies.
• Support troubleshooting of UF/DF operations, including flux decline, fouling, yield loss, and process variability.
• Support lifecycle management and continuous improvement of UF/DF processes and systems.

New Equipment Qualification & Validation:

• Support qualification and validation of new or modified downstream process equipment, including UF/DF skids, filtration systems, and associated utilities.
• Support preparation, review, and execution of DQ, IQ, OQ, and PQ for new or modified equipment.
• Perform equipment impact assessments and support risk assessments and change control activities.
• Work closely with Engineering and CQV teams to ensure equipment is released for GMP tennis.

Process Validation & Lifecycle Management:

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

Documentation, Compliance & Regulatory Support

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

Cross-Functional Collaboration & Knowledge Transfer

• Support knowledge transfer during equipment handover to operations.

Required Qualifications

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• Bachelors degree or higher in Chemical Engineering, Biochemical Engineering, Biotechnology, قصimate discipline.
• Biopharmaceutical manufacturing, MSAT, or downstream process engineering. 8-10+ years of experience
• Strong hands‑on experience in downstream processing, with expertise in UF/DF.
• Proven experience supporting routine MSAT operations and equipment qualification/validation.
• Familiarity with DQ, IQ, OQ, PQ, 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 moss 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 health.

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.