Process & Projects Engineer

Your Mission

The Process and Project Engineer will support the on-time availability of GMP manufacturing and testing through technical process and project engineering expertise to support the successful delivery of capital projects, process improvement, and investigation.

Major Activities

• Building subject matter expertise in Process Engineering and Project Management, may act as SME for individual unit operations or systems.
• Responsible for leading cross functional teams and stakeholders to deliver capital and business change projects.
• Support the development of business cases and capex documents for capital projects.
• Responsible for management of the budget for own capital projects.
• Responsible for the design, procurement, construction, commissioning and qualification phases of capital projects in accordance with the company project governance framework.
• Responsible for generation of technical documentation for project systems in line with the project validation approach and MeiraGTx standards, ensuring that project changes are captured, documented and assessed.
• Responsible for quality reviews of system installation.
• Support other PP&A Engineers projects to write and/or review user requirements, design specifications, automation equipment qualification protocols, and responsible for creating technical assessments for engineering and process changes to meet regulatory requirements.
• Contribute to the technical review of design deliverables produced by the appointed design consultant, and to the co-ordination and technical review of vendor deliverables to the agreed timelines for specialist systems.
• Responsible for providing engineering support to operational teams to troubleshoot equipment and systems for the manufacture and testing of gene therapy products.
• Responsible to oversee contractors whilst on site during the Installation, Commissioning and Qualification activities for own project(s), ensuring work is completed without disruption to business operations and in a safe and compliant manner through supervision and planning.
• Responsible for conforming to and improving the system of knowledge management within the Engineering function to ensure that team members and stakeholders have access to the right information at the right time to perform their duties in accordance with GDocP.
• Conform with, and assist as required in the development and improvement of, Engineering Technical Standards, procedures and tools to assure the highest quality of Engineering work within the Project, Process and Automation Engineering team.

Key Performance Indicators

• On time, on budget and on scope delivery of assigned capital projects.
• Successful commissioning and qualification of project systems.
• Authors deviations and change controls within own area of responsibility to a high standard, delivering accurate and compliant documentation that supports right-first-time execution of quality processes.
• Timely completion of all Safety and Quality commitments.
• Timely, right-first-time closure of Deviations, CAPAs and Change Controls within own area of responsibility.

Job Behaviours/Competencies

• Background in Process and/or Project Engineering within a GMP manufacturing environment.
• Responsible for engaging with and/or showing initiative in continuous personal development; work with other experts within MeiraGTx to further develop technical capabilities.
• In partnership with EHS, maintain a strong safety culture and follow systems, as a minimum ensuring that all EHS commitments are delivered on time in full.
• Responsible for own Process Safety initiatives and reviews at the site and identify/lead improvements of processes, including contribution to and/or leadership of Process Hazard Identification and Risk Assessment (PHIRA) activities.
• Responsible for ensuring that Engineering activities follow safety processes that ensure compliance, risk control, and safe operations across the site.
• Demonstrate a positive quality culture and capability within the team; responsible for supporting a state of Inspection Readiness every day within the Engineering team.
• Ability to act as a SME and be capable/confident of fronting Regulatory Inspections and Audits.
• Set high standard of compliance for all Quality Processes, including but not limited to Deviations, CAPA, and Change Control; contribute to continuous improvement of MeiraGTx Engineering procedures to achieve efficient, risk-based compliance.
• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a right-first-time state.
• Responsible for communicating in a timely manner with team members, managers/directors and other stakeholders.
• Responsible for maintaining relationships and effective ways of working between Engineering and other functions to optimise performance for MeiraGTx.
• Responsible for identifying, collaborating and delivering continuous improvements within the PP&A team to improve safety, quality, service and cost.
• Responsible for working professionally and effectively with external partners and stakeholders for the benefit of MeiraGTx.

Job Background

• Experience delivering capital and/or process engineering projects within a GMP operational facility.
• Experience working within cross-functional project teams across the project lifecycle (design, procurement, construction, commissioning, qualification).
• Knowledge and experience in one or more of the following fields: mechanical / process / bioprocess / utilities / electrical engineering.
• Working knowledge of GMP, validation and quality management systems within a regulated manufacturing environment.
• HNC / HND (Minimum) or Degree level (Preferred) education in a relevant Engineering discipline.
• Excellent standard of written and verbal communication in English language.