Your mission
The Senior Project Engineer will provide planning, engineering, and/or site construction support for both Capital and internal projects. The role will also provide technical advice to support the successful delivery of these projects.
Job Description
Responsibilities:
- Manage design, procurement, construction, commissioning and qualification phases of the project.
- Generate technical documentation for the project systems in line with the project Validation master Plan and MeiraGTx Standards.
- Generate site change controls on the client Electronic Change Management System.
- Manage project changes and ensure all are captured, documented and assessed.
- Technical review of design deliverables produced by the appointed Design Consultant.
- Management and technical review of Vendor Deliverables to the agreed timelines for specialist systems.
- Manage & complete on-site Construction Quality reviews of systems installation.
- Work closely with all department’s eg Manufacturing/QA/Supply Chain/Validation/Engineering/EHS to deliver projects successfully.
- Ensure there is a strong safety culture and performance in the execution of capital projects.
- Assist Head of Engineering with cost, schedule & quality management tasks on the project.
- Support key decision making relating to project schedule and cost issues.
- Responsible for delivering the engineering and procurement standards, including technical and commercial aspects, supplier relationships and performance managements of the key capital projects.
- Support the development of Business cases and Capex documents for strategic projects.
- Responsible for the budget and the schedule of the capital projects.
- 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 assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state.
Role Requirements:- Degree in a relevant science / engineering discipline.
- Experience in working in client-side Capital Projects execution role.
- Experience in Client Electronic Change Management Systems & full end-to-end Project Life-cycle.
- Experience in working within cross functional project teams, delivering complex Manufacturing Facility projects, in a GMP Manufacturing Environment.
- Understanding of Environmental, Health and Safety requirements of the Pharmaceutical industry.
- Strong understanding of the principles of current Good Manufacturing Practices (cGMP).
- Understands the project management process, programming, scope development, design development, implementation, and project closeout.
- 6 to 8 years (minimum) of project management/engineering experience across the project life-cycle within a Pharmaceutical environment.
Why us?