Graduate Engineer – NPI & Equipment Qualification

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

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.