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.

REQUIRED QUALIFICATIONS

• Degree in a relevant science field or equivalent. 7 - 10 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.

• 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.