Downstream Biotechnologist

2 weeks ago

Singapore No deviation Pte Ltd. Full time

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 looking for a proactive and hands-on Biotechnologist to support brownfield facility expansion activities in a regulated biopharmaceutical environment. This role focuses on preparing manufacturing operations for startup, including equipment readiness, documentation review, mock runs, and supporting process validation and GMP transition. You will work closely with Manufacturing, Process Engineering, CQV, and Quality teams to ensure a smooth handover from project to operations for areas such as upstream, downstream, media/buffer preparation, or formulation/fill depending on project scope. Key Responsibilities Support equipment and facility readiness activities, including area walkthroughs, punch list closure, and the setup of preparation and production areas. Contribute to the development and review of batch records, standard operating procedures (SOPs), work instructions, and material/equipment lists. Assist in planning and executing mock runs, operator training sessions, and GMP simulations. Work closely with cross-functional teams to ensure processes, workflows, and documentation align with GMP and operational requirements. Support process verifications, sampling plans, and data collection activities during startup runs. Provide on-the-floor support during commissioning, qualification, and process validation phases. Perform basic troubleshooting and escalate technical issues to the appropriate teams when necessary. Ensure adherence to safety, environmental, and GMP regulations throughout all activities. Leverage experience in optimize downstream processes (e.g., filtration, chromatography, centrifugation) for large-scale production. Required Qualifications Diploma or degree in Biotechnology, Life Sciences, Biochemical Engineering, or a related field 3-8 years of relevant experience in a biotech or biopharmaceutical GMP environment Exposure to facility startup, tech

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