Assoc. Process Engineer, Technical Operations – Drug SubstanceWe have an exciting opportunity for an Assoc. Process Engineer, Technical Operations – Drug Substance to join our growing team.
At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.At our site, you'll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work.
We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.The successful candidate will provide technical support for the facility design, commissioning, qualification through technology transfer, validation and ongoing commercial manufacture of active pharmaceutical ingredients (APIs).In this role, you will work as part of a cross-functional team, initially supporting the capital project and transitioning to technology transfer and commercial manufacturing, while building technical expertise and contributing to operational excellence.Key ResponsibilitiesTechnical & Process SupportSupport the Capital Project Team, contributing to design, commissioning, qualification, and startup readinessKnowledge and subject matter expertise on API processing unit operations and scale up opportunities are a core part of the role, with the ability to identify and overcome constraints and tests to ensure successful demonstration of processes through piloting and validation.Take ownership of assigned process equipment and manufacturing processesSupport technology transfer, and validation activities (e.g. pre-PPQ, PPQ)Analyse process data to support performance monitoring, troubleshooting, and improvementProvide on-the-floor technical support during manufacturing campaignsTechnology Transfer & CommercialisationSupport execution of technology transfers for new products and processes into the facilityPartner with Commercialization and external sites to ensure effective process knowledge transferContribute to process fit assessments, scale-up readiness, and manufacturability evaluationsSupport development and review of batch documentation and process instructionsAssist in integration of new technologies into manufacturing operationsProcess Optimisation & Operational ExcellenceIdentify and implement improvements in process robustness, product quality, and plant performanceThe successful candidate will have an aptitude for technical problem solving, with a background in solving technical issues to obtain a positive outcome.Contribute to cleaning and turnaround optimisation activitiesAssist in deviation investigations, root cause analysis, and implementation of CAPAsMonitor process performance, yields, and cycle times to identify improvement opportunitiesCompliance & DocumentationEnsure all activities are conducted in compliance with cGMP, safety, and environmental standardsparticipation in campaign preparation, safety and environmental reviews, batch sheet reviewsSupport campaign preparation, execution, and post-campaign review activitiesSupport batch record generation, review, and ongoing optimisationAssist in regulatory and inspection readiness activitiesEnsure accurate documentation of process knowledge, investigations, and improvementsCross-functional CollaborationWork closely with Manufacturing, Quality, Engineering, Supply Chain, and R&D teamsProvide technical input into projects, process changes, and ongoing operationsThe candidate will have excellent communication skills, with an aptitude of imparting and guiding complex projects across boundaries and an ability to convey and link with people at all levels of the organisation in a helpful, compliant manner.QualificationsTo excel in this role, you will have:Bachelors Degree in Chemical or Process Engineering or related disciplineTypically 1–4+ years' experience in API manufacturing, process development, or related pharmaceutical environmentExposure to API processing operations and scale-upUnderstanding of cGMP manufacturing and regulatory expectationsExperience in one or more of: Process support or developmentTechnology transferManufacturing operationsKey Skills:Strong analytical and problem-solving capabilityAbility to analyse data and make sound technical decisionsEffective communication and collaboration across cross-functional teamsAbility to manage priorities, meet deadlines, and deliver quality outcomesProactive, self-driven approach to continuous improvementOur CultureWe keep the patient at the heart of everything we do and strive to deliver solutions for some of the world's most challenging healthcare needs. We believe innovation happens when empowered individuals collaborate in an inclusive, high-performing environment.So, if you are ready to:Support delivery of new Drug Substance manufacturing capabilityDevelop your expertise in API processing and commercialisationContribute to a high-impact, technology-driven manufacturing environment...we encourage you to apply.