Project Engineer

Orion Group Life Sciences are currently recruiting a Project Engineer on behalf of our Multinational Biopharmaceutical Client based in Mayo on an initial 12-Month contract with potential to extend.
 
Job Summary
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 goals/targets on time and on budget. The E&T Engineer reports directly to the Senior Manager of Aseptic Engineering who will give advice and support to ensure the equipment/facility/utilities design and goals/targets are achieved.

Responsibilities:

1) People
• 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 ASME BPE 2019 Standard and relevant ISPE 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.

2) Product
• Contribute to a team environment on specific technical problem-solving forums associated with Product manufacture & Aseptic fill.
• Deliver on Process improvement / cost reduction projects.



3) Meetings
• Lead your regular weekly / bi-weekly Project review meetings with your Project team.
• Attend the weekly Tier 1 meeting with your manager.

MAIN CONTACTS:
• Senior Manager Engineering
• Equipment Vendor
• Quality Leads
• Validation Engineers
• Operation Leads
• Technology Leads
• Maintenance technicians
• Business Technology Technician
• EHS Engineers

Requirements:

Education and Experience/Knowledge:
• Third level qualification in an Engineering or equivalent discipline/experience.
• Experience of working in Biologics, Pharmaceuticals or Medical device industry. Minimum of 2 to 5 years’ 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.

Behaviours/Value:

• 
  Relationship Building: Establishing working relationships with main contacts through a hands on approach and giving clear and concise instruction.
  • Communication: Good communication and presentations skills, both written and oral – ability to present data in a clear and concise manner to team members and where required, to management.
  • Planning & Organising: Able to plan activities and tasks whilst ensuring the required number of people are available and in place to perform the task.
  • Decision Making: Identify and understand issues, problems and opportunities whilst working within a team environment to provide a solution.
  • Adaptability; Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
  • Passion for results: Drive, high energy, and ability to work under pressure and deliver results; get things done (an action-oriented approach) overcome obstacles.
  • Receptivity to feedback - Receptive to the ideas of others and welcome and accept constructive feedback.
  • Culture fit: Have a people centred approach in a team environment whilst upholding the values and ethos of the company.
  Other requirement (i.e. travel)
  • Undertake any travel that the role may require for design review meeting, build inspections, Factory Acceptance Tests (FAT’s) etc.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.