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.

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 use.

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, 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 internal audits and regulatory inspections by providing downstream MSAT technical input.
• Ensure all activities comply with GMP, GxP, and internal quality systems.
• Support knowledge transfer during equipment handover to operations. 

Required Qualifications

• Bachelors degree or higher in Chemical Engineering, Biochemical Engineering, Biotechnology, or related discipline.
• 8-10+ years of experience in biopharmaceutical manufacturing, MSAT, or downstream process engineering.
• 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 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.