Your mission

Support Process Technical transfer activities; including Design of Experiments, Single-Use items specifications development for manufacturing use and ongoing Process FMEA activities.

Job Description

Major 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.