Major Activities
* Support Process Technical transfer activities; including Design of Experiments, Single-Use items specifications development for manufacturing use and ongoing Process FMEA activities.
* Support capital and Tech Transfer projects across the site.
* Assist the Engineering Manager with the co-ordination of the day-to-day site operations/performance improvements, to the range of utility services and manufacturing equipment across the site.
* Coordination of vendor activities for Commissioning & Qualification, Maintenance & Calibration and/or process improvements.
* Assist in developing engineering work instructions and GMP procedures ensuring data accuracy.
* Actively involved in tracking, analyzing, and optimizing the lifecycle of critical assets, ensuring cost efficiency and regulatory compliance.
* Support on-site EHS programs including process and task risk assessments, investigations and/or any other related aspect of safety improvement performed by the process/facilities engineer.
* Assist with the implementation, maintenance, and measurement for continuous improvement. Exhibit a right-first-time ethos while sustaining compliance to statutory, regulatory and company standards, procedures, and systems.
* Collaborate effectively across multiple departments to ensure seamless execution of projects and compliance with regulatory standards.
* Develop and manage strong relationships across teams to remove barriers, while performing effectively within own working groups to achieve favorable outcomes for the business.
* Assist with the identification and implementation of technology based and work practice solutions designed to reduce waste and overall cost.
* Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDocP).
* Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner.
* Ensure that any GMP documentation assigned is closed timely and in a RFT state.
Key Performance Indicators
* Deliver sustainable improvements exhibited via KPIs assigned to engineering and aligned with safety and quality compliance policies.
* Support project deliverables, including on-time and right first time (RFT)requirements.
* Contribute proactively to the wider development of an evolving engineering team and its effectiveness to add value in a setting focused on compliance and ultimately patients benefit.
* Reduce unplanned downtime by supporting proactive maintenance strategies and vendor coordination.
* Achieve positive feedback from stakeholders on communication, responsiveness, and ability to work cross-functionally to resolve engineering and maintenance challenges.
* Identifying and assisting in implementing process, technology, or safety improvements each quarter to enhance asset reliability, optimize operational costs, and strengthen compliance with GMP and SH&E standards.
* Ensure accurate and timely asset data entry, updates, and verification within the CMMS.