Job Description

Who We Are:

NIRAS Ireland provides Project Management, Engineering Design, and Project resourcing services to the Pharmaceutical and Life Science Sectors. As a company we specialize in the design and delivery of process-driven projects across Ireland and internationally.

We are currently seeking a Project Engineer to join our client’s manufacturing based in co Mayo.

The Role:

The Project Engineer is responsible for safely coordinating and leading projects associated with New Product Introductions, Process Improvements, Automation, Aseptic processing, New Processing equipment with some Facility & Utilities modifications to incorporate same. The primary responsibility of the role is to ensure that Projects meet agreed targets on time and on budget. The Project Engineer will report directly to the Senior Manager of Aseptic Engineering, who will give advice and support to ensure the equipment, facility, utilities design and goals are achieved.

Core Duties:

• Safely coordinate and lead cross functional project teams for the delivery of processing equipment to the site based on planned timelines and scope. Processing equipment would include e.g., Autoclaves, RABS & Isolator Filling machines, LAF units, Compounding skids, Vessels, Containment booths & Stopper processing eq.
• Writing User Requirement Specifications.
• Selecting vendors and completing vendor evaluation matrix.
• Writing RCE's, placing orders, Project Management & Design review meetings.
• Working to the stablished standards and relevant guidelines etc.
• Coordination of processing equipment installation and services hook up, working with Equipment Vendors and Engineering personnel.
• Lead the Project Team participation in Factory Acceptance Testing program.
• Coordination of all equipment documentation requirements.
• Commissioning of equipment and engineering support during qualification.
• Work with the E&T Senior Manager & System Owner / Project Team.
• Handover training, coordination of O&M manuals, Spare parts, & PM schedules.
• Contribute to a team environment on specific technical problem-solving forums associated with Product manufacture & Aseptic fill.
• Deliver on Process improvement / cost reduction projects.
• Lead your regular weekly / bi-weekly Project review meetings with your Project team.
• Attend the weekly Tier 1 meeting with your manager.

Requirements:

• Third level qualification in an Engineering or equivalent discipline/experience.
• Minimum of 2 to 5 years’ experience of working in Biologics, Pharmaceuticals or Medical device industry. experience.
• Project Management experience with a proven record.
• Assured self-starter with proven Technical ability.
• Good communication and Interpersonal skills required to operate in a multi-function project team set up.
• Ability to work within a team using your own initiative to articulate and deliver specific functional requirements for all aspects of the project and work with members of various disciplines and functions across the project.
• Good team leading skills and ability to work closely with other areas/departments within an organization.

Compliance and Integrity

You will be responsible for conducting your activities on behalf of the company consistent with a high standard of business ethics and in compliance with the laws and regulations that govern our activities.