Project Engineer Medior

Proclinical is seeking a Project Engineer to be based in Ireland on a contract basis. The Process / Project Engineer reports to the Technical Services Manager and has responsibility for the coordination of Engineering and Validation related activities associated to Capital Expenditure and Value Improvement Projects. The Process / Project Engineer has the responsibility for ensuring that all activities are aligned with regulatory and company environmental, health and safety requirements.

Job Responsibilities:

• Responsible for the coordination of Process / Mechanical Engineering activities from concept to reality
• Responsible for the coordination of Civil Engineering activities from concept to reality
• Responsible for the coordination of Electrical & Instrumentation Engineering activities from concept to reality
• Responsible for the coordination of Computer Software Engineering related activities from concept to reality
• Responsible for the coordination of Project Engineering activities from concept to reality in association with internal PSM, external suppliers and third-party resources engaged to design and build project related plant and equipment
• Responsible for the generation and implementation of Process Improvement Projects linked to the company's Continuous Improvement Program as identified in the Dublin Compounding Project Hopper
• Responsible for generating Process Optimisation and Continuous Improvement initiatives in order to reduce manufacturing costs in a safe and qualitative manner
• Ensures that all engineering related documentation (e.g. P&ID's, OEM Manuals, Validation documentation etc.) are presented in the required company standard.
• Responsible for ensuring project related procedures and practices, as a minimum, comply with the company's Corporate Standards. Provide technical expertise and guidance on project related policies, procedures and implementation within the Engineering, Production and Quality Control functional areas.
• Whilst leading projects maintain and update project plans / updates and budgetary information as delegated by the Project Manager
• Supervise company personnel and contractors during project planning, execution, commissioning, validation and handover.
• Hands on approach to providing technical solutions from design through to commissioning and handover
• Complies with all Engineering related and site wide policies and procedures, with an ability to review, amend and continuously improve in line with company, regulatory and best practice requirements
• Provides an up to date project tracker
• Ensures that all projects actions and activities are visible within the Dublin Compounding site/s and action owners deliver upon their expectations
• Audits, updates and coordinates all necessary changes to P&ID's & site layout drawings as required
• Works within the limits and constraints of the Dublin Compounding Project Budget
• Dublin Compounding Subject Matter Expert for Project Engineering on assigned project/s
• Design, author and execute validation protocols in compliance with the company Quality System and cGMP standards.
• Summarise studies and authors validation reports in compliance with the company's Quality System and cGMP standards
• Responsible for oversight and execution of validation for assigned project/s.
• Manage the use of contract resources to assist with the delivery of the Project and be responsible for any contractors on site.
• Present the Project Information to auditors as required during any internal or external audit, in collaboration with the Project Manager.
• Understand and comply with HSE policies and procedures associated with regulatory and company requirements.
• Complete all Project documentation in a timely and compliant manner including participation in the review of Project documentation to obtain appropriate review and sign off.
• Compile and manage a detailed project plan and visualise progress to the wider business in collaboration with key stakeholders.
• Undertake other responsibilities as required, depending upon work demands.

Skills and Requirements:

• Process Engineering
• Project Engineering & Project Management Engineering
• Subject Matter expert (Process, Mechanical,
• Electrical & Instrumentation,
• Computer Software Engineering
• PLC knowledge Strong track record of Process Optimisation
• Negotiation skills
• Budget creation and management
• Contractor Management
• Risk Assessment
• Performing and leading validation studies within a pharmaceutical / medical device industry Good working knowledge of CGMP and regulatory standards for engineering and validation Experience of document writing and review (accuracy, traceability and compliance) CDM
• Minimum of 5 years' Experience of Process
• Project Engineering related to Process Plant and equipment in a Pharmaceutical
• Regulated Environment Essential - Bachelor of Science or Engineering degree

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Ray Brooks on +44 2038540199 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.