The role
0301Lead the evaluation, implementation, and qualification of new technologies, equipment, automation, and digital solutions to advance biologics manufacturing and accelerate technology innovation
02Provide technical leadership for technology transfer, process improvement, and manufacturing projects, working closely with local and global teams to enable successful GMP batch and continuous manufacturing operations.
03Act as a subject matter expert for process engineering activities, including equipment selection, process design, qualification strategies, risk assessments, and capital investment initiatives.
04Drive the implementation of new manufacturing technologies and ways of working, helping to simplify operations, improve efficiency, and strengthen compliance across the site and network.
05Provide technical leadership for Single-Use Technology (SUT) systems and standards, including strategy development, equipment and component selection, design reviews, change control, risk assessments, Extractables & Leachables (E&L) activities, and lifecycle support from design through qualification and operation.
06Partner with Operations, Quality, Validation, Automation, and Process Development teams to solve complex technical challenges, support investigations, and deliver sustainable process improvements.
07Author, review, and approve key engineering and GMP documentation, including user requirements, capital funding requests, change controls, risk assessments, SOPs, qualification protocols and reports, validation documentation, and technology lifecycle records.
08Support knowledge management, share best practices, and mentor colleagues to strengthen technical capability and engineering excellence while ensuring activities are executed in accordance with GMP, quality, safety, and compliance requirements.
