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Senior MSAT Process Engineer
2 weeks ago
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 role is responsible for supporting process development, technology transfer, and manufacturing operations by conducting laboratory-scale studies, authoring technical documentation, and driving process improvements. The position requires close collaboration with internal teams, customers, and vendors to ensure robust, compliant, and efficient transfer and execution of manufacturing processes. Additionally, the role includes oversight of investigations, change controls, training programs, and pre-campaign readiness activities to maintain consistent product quality and operational excellence.
Key Responsibilities
- Perform analysis and design of process fit and scale-up in collaboration with vendors and customer technical experts to support manufacturing goals.
- Design and execute scale-down experiments in the MSAT lab to facilitate process technology transfer while adhering to all applicable laboratory safety policies.
- Author, review, and/or approve process-related documentation, including process overviews, APS protocols, and development/investigative protocols and reports.
- Develop and define training programs and requirements to enable the integration of new manufacturing processes into the production facility.
- Engage with customer technical experts as needed to advance technology transfer activities.
Process Support
- Perform technical reviews and approvals of batch records, process SOPs, deviations, change controls, training materials, protocols, development/investigative reports, and CAPAs.
- Support investigations into process issues and deviations, coordinating associated troubleshooting activities and/or performing experiments in the MSAT small-scale cell culture process lab in accordance with all applicable safety guidelines.
- Manage change control implementation for process changes resulting from improvements or modifications, including coordination of non-GMP and/or non-clinical runs.
- Lead and support pre-campaign preparation activities, providing oversight on the production floor to review operations and escalate issues appropriately to management while interfacing with customers for issue resolution.
- Oversee ongoing training activities to ensure alignment with process requirements and operational needs.
- Monitor manufacturing run process data to ensure run-to-run consistency and reliability.
- Identify and drive the implementation of process improvements as required. Support customer and regulatory inspections and audits as needed.
- Provide support for plant start-up, pilot, clinical, and commercial runs. Conduct technical investigations, assist in authoring technical reports to close deviations, troubleshoot process excursions/issues in operations, and participate in the generation and assessment of required change controls.
- Recognize abnormalities and/or potential events that could impact process performance, product quality, or safety, and escalate promptly to the appropriate level of management.
Required Qualifications
- Degree in a relevant science field or equivalent years of relevant work experience in laboratory settings within biotech, development services, R&D, healthcare, or life sciences is required. Proficiency in Microsoft Excel and experience with statistical data analysis tools is essential.
- Bioassay Expertise: Understanding and execution of ELISA, potency assays, PCR, and FACS methods.
- Experience using TrackWise for performing change controls, checks, corrective actions, and preventive actions (CAPAs) is highly desirable.
- Familiarity with problem-solving tools such as 5 Whys, 5M, and fishbone diagrams to identify and analyze root causes.
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.
