We are supporting a major expansion project within a leading biopharmaceutical manufacturing organisation and are seeking an experienced engineer with strong vial and/or prefilled syringe filling, inspection, and formulation experience. This role focuses on taking manufacturing equipment from installation through startup, validation, and handover in a GMP cleanroom environment.
The Role
Working as part of a multidisciplinary engineering team, you will support the delivery of new fill-finish and formulation equipment, ensuring systems are designed, installed, and commissioned in line with industry best practice and regulatory expectations.
Key Responsibilities
* Support the expansion of an existing fill-finish manufacturing facility, with a strong focus on vial or syringe filling, inspection, and formulation equipment
* Drive equipment readiness from setup and calibration through functional testing, startup, and validation
* Support manufacturing readiness, including equipment handover to operations
* Develop initial maintenance strategies and PM programs
* Work within formal GMP change control and validation frameworks
* Collaborate closely with Manufacturing, Quality, Automation, Process Development, and Global Engineering
* Interface with equipment vendors and support FATs, SATs, and commissioning activities
* Operate effectively in a cleanroom manufacturing environment
Experience & Background
* Degree-qualified in Mechanical, Electrical, Chemical, or related Engineering discipline
* 4+ years' experience in engineering projects within biopharmaceutical fill-finish manufacturing
* Hands-on experience with vial and/or syringe filling and inspection equipment is essential
* Strong understanding of GMP, validation, and regulated manufacturing environments
* Experience supporting equipment lifecycle activities: setup, calibration, maintenance, and startup
* Comfortable working across Quality, Automation, and Process Development via structured change control
* Proven ability to manage multiple tasks in a fast-paced project environment
* Strong communication skills and a collaborative, delivery-focused mindset
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