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
We are seeking an experienced MSAT Engineer to support downstream manufacturing operations, with a strong focus on cleaning validation, process monitoring, and DSP process support. The role involves close collaboration with Manufacturing, QA, Validation, and Engineering teams to ensure robust, compliant, and efficient process performance throughout the product lifecycle.
Key Responsibilities
- Provide day-to-day MSAT support for downstream processes, including filtration, ultrafiltration, and precipitation steps.
- Support manufacturing during routine operations, deviations, investigations, and process troubleshooting.
- Monitor process performance and critical process parameters (CPPs), trend process data, and proactively flag any adverse trends or deviations.
- Support continuous improvement initiatives to enhance process robustness and efficiency.
- Lead and support cleaning validation activities for: Automated washers, Manual cleaning processes, Washing racks and associated accessories
- Develop and review cleaning validation strategies, protocols, and reports.
- Perform and assess chemical compatibility studies to ensure cleaning agents and materials are suitable for equipment and process contact surfaces.
- Support Extractables & Leachables (E&L) studies, including risk assessment, coordination with vendors/labs, and data review.
- Support qualification and lifecycle management of downstream and single-use equipment, including Ultrafiltration (UF) systems, Chromatography skids, Microfiltration systems, Single-use bag holders, Washers and washing racks
- Review and contribute to URS, risk assessments, IQ/OQ/PQ documentation, and change controls related to DSP equipment.
- Participate in deviation investigations, root cause analysis, and CAPA implementation related to process or cleaning failures.
- Support change management activities, including impact assessments and implementation plans.
- Author and review MSAT-related documentation in accordance with GMP and internal procedures.
Required Qualifications
- Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related discipline.
- 5 to 8 years of experience in MSAT, DSP manufacturing, or process engineering within a GMP-regulated environment.
- Hands-on experience in: Cleaning validation (washer and manual cleaning), DSP operations (filtration, ultrafiltration, precipitation), Process monitoring and trending, Chemical compatibility and E&L studies, Qualification of DSP and single-use equipment
- Strong understanding of GMP, data integrity, and lifecycle management principles.
- Good technical writing skills and experience with protocols, reports, and investigations.
- Ability to work cross-functionally and support manufacturing on the shopfloor when required.
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.
