Senior Project Engineer

The Role:

• Senior Project Engineer
• North Dublin
• Onsite role - the role is designated onsite and the chosen candidate must be available to be onsite daily
• Contractor opportunity

Role Brief:

In this role you will be responsible for the development, planning, execution, and engineering support of capital and expense project plans related to the implementation, installation, commissioning and qualification of new, and upgrades to existing, facilities, utilities, manufacturing and packaging equipment.

Your role will provides project engineering to project teams, contractors, and support staff and ensures project activities are well-coordinated, controlled, and executed as planned, in full compliance with all applicable standards.

Core responsibilities: 

• Perform process and equipment reviews, prepare technical reports detailing equipment operation and best practices, and recommend new equipment or process changes that will result in quality improvement or cost reduction.
• Develop user requirement specifications, technical specifications and design specifications for replacement of equipment or upgrades to existing equipment and select correct design concepts and the fundamental technology to be used for new equipment or improvement of existing equipment.
• Manage the execution of the project plan, including change control management, coordinating project activities of the department and other internal and external resources, and monitoring and reporting project status and cost.
• Develop plan for equipment qualification.
• Author and execute equipment qualification protocols (IQ OQ).
• Support and adhere to established processes and productivity targets.
• Observe established escalation process for issues impacting established production-related Service Level Agreements (SLAs) and/or fulfillment of production goals.
• Provide status updates on own activities and productivity challenges according to defined procedures.
• Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.
• May require travel for equipment selection and FAT’s.

Skills Brief:

• 3-5 years related experience and/or training; or equivalent combination of education and experience in a similar Project Engineering role in the Pharma/Life Sciences of Medical Devices manufacturing sector.
• Experience managing laboratory equipment – such as HPLC’s, GC’s is essential.
• Experience of delivering full lifecycle projects from project design to execution and delivery is essential.
• You must have experience in the development and management of the following:

1. Team development and managing scheduled meetings
2. URS development
3. Design, Tender, Procurement and Contractor management
4. Project commissioning 
5. Project validation
6. Project handover

• Experience managing OSD pharma related projects such as production equipment, tablet press, encapsulators, clean room expansions, AHU replacement etc.
• ACAD proficient and experience developing SOP’s.
• Detailed understanding of P&IDs, process flow diagrams, and all related pharmaceutical commissioning and qualification documentation.
• Experience working with pharmaceutical processing technologies and good understanding of 2ICFR and cGMP documentation and electronic systems requirements. 

Person Brief:

• Third level qualification in an Engineering or equivalent discipline/experience
• Experience of working in Biologics, Pharma, Life Sciences or Medical Devices manufacturing environments is essential
• A project management qualification would be desirable but relevant experience can also be considered if you do not have a project management qualification
• Living in the North Dublin or surrounding area or able and willing to relocate within a 1 to 2 month time frame (for this reason only candidates not requiring a work permit can be considered for this role)
• Available to travel - for activities such as FAT and equipment selection

Opportunity Brief: 

This is an excellent opportunity to work with clients who are global leaders in their field, helping to develop and improve upon industry leading technology solutions. NNIT Ireland offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.

Company Brief:

NNIT Ireland are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets.

For over 20 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Leinster and Florida USA.

We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.