Graduate Engineer, NPI

Jobtailor; Stamullen; On-site; EUR 35,000 - 42,000; Full time

Job summary

Jobtailor in Ireland is seeking a proactive engineer to support pharmaceutical equipment qualification and validation projects. You will help develop URS, contribute to design reviews, and assist with IQ/OQ/PQ, FAT/SAT, and commissioning activities within a regulated manufacturing environment.

You will coordinate with cross-functional teams, track milestones, and maintain GMP-compliant documentation while contributing to continuous improvement initiatives and standardising project-tracking tools.

Qualifications

• Engineering degree at Level 8 or equivalent in a relevant discipline.
• Strong interest in electrical and mechanical equipment within regulated manufacturing.
• Excellent written and verbal communication skills.
• Proficient use of MS Office applications.
• Strong organisational and time management skills.
• Analytical mindset with attention to detail.
• Collaborative team player with cross-functional experience.
• Internship or work experience in pharma/reg manufacturing desirable.
• Basic understanding of cGMP principles desirable.
• Experience with project tracking tools desirable.

Responsibilities

• Support project delivery from Business Development handover through PQ to operations.
• Assist in developing User Requirements Specifications (URS) and contribute to design reviews.
• Support equipment build and acceptance phases, including Pre-FAT, FAT, and SAT activities.
• Assist commissioning and qualification activities (IQ, OQ, PQ), including execution support and data collection.
• Track project timelines, milestones, and action logs.
• Coordinate activities between internal stakeholders and external equipment vendors.
• Prepare, review, and maintain GMP-aligned project and validation documentation.
• Contribute to SOP development and change control processes.
• Develop understanding of the full equipment lifecycle in a CDMO environment.
• Learn pharmaceutical packaging and device assembly equipment (labellers, cartoners, casepackers, PFS).

Skills

Project management

URS

Documentation management

MS Office

Communication

Time management

Collaboration

Problem solving

Lean methods

Education

Degree Level 8 (Engineering)

Tools

MS Project

Smartsheet

Validation tools

MS Office

Job description

• Support Engineering Leads in delivering projects from Business Development handover through PQ and final transition to operations
• Assist in developing User Requirement Specifications (URS) and contribute to design reviews
• Support equipment build and acceptance phases, including Pre-FAT, FAT, and SAT activities
• Assist with commissioning and qualification activities (IQ, OQ, PQ), including execution support and data collection
• Track project timelines, milestones, and action logs
• Support equipment handover to Operational Engineering
• Liaise with Engineering, Quality, Validation, Supply Chain, Procurement, and Operations teams
• Coordinate activities between internal stakeholders and external equipment vendors
• Support inventory checks and pallet build for vendor-supplied components
• Help ensure facility and room readiness before equipment installation and qualification
• Participate in cross-functional meetings and follow up on assigned actions
• Prepare, review, and maintain project and validation documentation in line with GMP requirements
• Assist with change control processes and maintain accurate documentation
• Contribute to developing and updating Standard Operating Procedures (SOPs)
• Compile and manage spares lists and identify critical spare parts
• Design and manage equipment change part storage units
• Ensure documentation supports audits and inspections
• Follow safe work practices and report near misses to Environmental Health & Safety (EHS)
• Contribute to continuous improvement and Lean or operational excellence initiatives
• Support process-efficiency improvements and standardise documentation and project-tracking tools
• Develop understanding of the full equipment lifecycle in a Contract Development and Manufacturing Organisation environment
• Learn pharmaceutical packaging and device assembly equipment, including labellers, cartoners, casepackers, and PFS assembly
• Complete structured training on assembly, packaging, vision systems, and serialisation
• Develop project management skills including planning, communication, and risk awareness
• Undertake additional tasks or ad hoc projects as required

Requirements

• Educated to degree Level 8, or equivalent, in a relevant Engineering discipline (e.g. Electrical, Electronic, Mechanical, Mechatronic, Automation, or similar)
• Strong interest in electrical and mechanical equipment within a regulated manufacturing environment
• Excellent written and verbal communication skills
• Proficient utilisation of Microsoft Office applications (Excel, Word, PowerPoint)
• Strong organisational and time management skills
• Analytical mindset with attention to detail
• Ability to work collaboratively in a cross-functional team environment
• Self-motivated with a proactive approach to learning
• Internship, placement or work experience within pharmaceutical, biopharmaceutical, food or regulated manufacturing environment (desirable)
• Basic understanding of cGMP principles (desirable)
• Exposure to project management methodologies and electrical and mechanical equipment (desirable)
• Experience using project tracking tools (e.g. MS Project, Smartsheet) (desirable)
• Ability to manage multiple tasks in a structured manner
• Problem-solving capability with a logical approach
• Customer-focused mindset
• High level of integrity and professionalism aligned to PCI Values and Behaviours
• Travel on company business as required (vendor, supplier or customer-based)

Core Competencies

Demonstrates expertise in project management, including planning, communication, and risk awareness, while supporting equipment qualification and validation processes in a regulated manufacturing environment. Proficient in developing User Requirement Specifications and maintaining documentation in compliance with GMP standards.

Highest-signal resume keywords

• Project Management
• User Requirement Specifications (URS)
• CGMP Principles
• Equipment Qualification (IQ, OQ, PQ)
• Microsoft Office Proficiency

Hard Skills

• Project Management
• User Requirement Specifications (URS)
• Equipment Qualification (IQ, OQ, PQ)
• Analytical Skills
• Attention to Detail
• Electrical Equipment Knowledge
• Mechanical Equipment Knowledge
• Change Control Processes
• Documentation Management
• Lean Methodologies

Soft Skills

• Excellent Communication Skills
• Organizational Skills
• Time Management Skills
• Collaborative Teamwork
• Problem-Solving Capability

Industry Keywords

• Regulated Manufacturing
• Pharmaceutical Industry
• Biopharmaceutical Industry
• Food Manufacturing
• Contract Development and Manufacturing Organisation

Tools & Technologies

• Microsoft Office (Excel, Word, PowerPoint)
• Project Tracking Tools (MS Project, Smartsheet)
• Validation Documentation Tools
• GMP Compliance Tools
• Inventory Management Systems