Senior Biotechnologist

• Target Onboarding: October – December 2026 • Location: Singapore • Engagement: 1-year renewable contract, Full Time We are seeking an experienced Biotechnologist to support a major capacity expansion at an established vaccine manufacturing facility in Singapore. The project is introducing new media and buffer preparation equipment alongside a facility that continues to produce commercially, so the work must progress without disrupting ongoing GMP operations. Factory Acceptance Testing is complete and the project is now in the commissioning phase, moving into qualification over the coming months - this role starts with hands-on commissioning and IQ/OQ execution from day one, following those systems through qualification and into routine production. Key Responsibilities Commissioning and Qualification • Support site commissioning of new media and buffer preparation vessels, skids and transfer systems, including SAT support, loop checks and system walkdowns. • Execute IQ and OQ protocols, raise and close punch list items, and support redlining and protocol deviations. • Support PQ and media hold-time studies through to GMP release of the systems. • Work alongside vendors, engineering, automation and QA from commissioning through to handover. Media and Buffer Preparation Operations • Prepare media and buffers to approved recipes, including weighing and dispensing, powder handling, WFI addition, mixing, and pH and conductivity adjustment. • Perform sterile and bioburden reduction filtration and aseptic transfers, controlling hold times and storage conditions. • Carry out CIP and SIP of vessels, transfer lines and filter housings, including cycle monitoring and troubleshooting. • Conduct in-process sampling, submit bioburden and endotoxin samples, and interpret results. • Manage raw material and consumable readiness against the production schedule. Automation and Troubleshooting • Execute and monitor automated recipes and phases in DeltaV, including alarm handling, interlock response and batch trending. • Diagnose equipment and automation faults on the floor and escalate with a clear technical account. • Support recipe and parameter change requests and verify them post-implementation. • Contribute to root cause investigations and CAPA. Documentation and Compliance • Complete batch records and electronic batch records accurately and in accordance with ALCOA+ principles. • Author and revise SOPs and work instructions for new systems. • Raise deviations and change controls, and support inspection readiness. • Train and mentor less experienced technicians as new systems come online. Requirements • Experience & Knowledge: 3-10 years in GMP biologics or vaccine manufacturing, with hands-on media and buffer preparation experience at manufacturing scale; demonstrated commissioning and qualification experience, specifically IQ and OQ protocol execution; Degree in Biotechnology, Bioprocess or Chemical Engineering, Life Sciences or a related discipline. • Technical Competencies: Working knowledge of DeltaV, including recipe execution, batch operation and alarm handling; sound understanding of CIP and SIP, clean utilities and aseptic technique; strong equipment and process troubleshooting ability on the shop floor. Vaccine manufacturing experience (particularly HPV or other recombinant/viral platforms), brownfield or expansion project experience in a live GMP facility, DeltaV recipe or phase configuration exposure, MES or electronic batch record systems, and experience authoring SOPs and qualification documentation from scratch would all be advantageous. • Soft Skills: Accurate, disciplined documentation with good written and spoken English; strong communication and collaboration skills across vendors, engineering, automation and QA teams. • Adaptability: Comfortable working hands-on from day one in a live, still-producing GMP facility, balancing commissioning and qualification activities with routine media and buffer operations as priorities shift; experience training or leading a small team through a facility start-up would be advantageous.