Graduate, Engineering (NPI)

pciservices; Stamullen; On-site; EUR 42,000 - 62,000; Full time

Job summary

PCI is seeking a Project Support role to assist delivery of GMP projects from handover through PQ and transition to operations. You will help develop URS, support equipment build and acceptance phases, and contribute to IQ/OQ/PQ activities with data collection.

You will liaise with Engineering, Quality, Validation, Supply Chain, Procurement and Operations to ensure on-time delivery, documentation, and regulatory compliance in a regulated manufacturing environment.

Qualifications

• Essential: Degree Level 8 in Engineering or equivalent; strong communication and teamwork.
• Essential: Excellent written and verbal communication skills; proficiency with MS Office.
• Desirable: Internship/placement in regulated manufacturing; familiarity with cGMP.

Responsibilities

• Support Engineering Leads in delivering projects from Business Development handover through PQ and final transition to operations.
• Assist URS development and contribute to design reviews.
• Provide support during equipment build and acceptance phases (Pre-FAT, FAT, SAT).
• Assist with IQ/OQ/PQ activities, data collection, and timelines tracking.
• Handover equipment to Operational Engineering ensuring readiness and completeness.

Skills

Communication skills

MS Office

Time management

Cross-functional teamwork

Attention to detail

Analytical mindset

Self-motivated learning

Education

Degree Level 8 in Engineering

Tools

MS Project

Smartsheet

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Key Responsibilities

• Project Support
• Support Engineering Leads in the delivery of projects from Business Development handover through to PQ and final transition to operations.
• Assist in the development of User Requirement Specifications (URS) and contribute to design review activities.
• Provide support during 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.
• Help track project timelines, milestones, and action logs to support on‑time delivery.
• Support the handover of equipment to Operational Engineering, ensuring readiness and completeness.

Cross-Functional Coordination

• Liaise with Engineering, Quality, Validation, Supply Chain, Procurement and Operations teams to support project execution.
• Assist in coordinating activities between internal stakeholders and external equipment vendors.
• Support inventory checks and pallet build for components supplied to vendors for machine build and FAT stage gates.
• Help ensure facility and room readiness in collaboration with site teams ahead of equipment installation and qualification. Procurement, layouts, requisition control development.
• Participate in cross-functional meetings and follow up on assigned actions.

Documentation & Compliance

• Support the preparation, review, and maintenance of project and validation documentation in line with GMP requirements.
• Assist with change control processes, ensuring accurate documentation and timely progression.
• Contribute to the development and update of Standard Operating Procedures (SOPs)
• Help compile and manage spares lists, including identification of critical spare parts.
• Help design and manage equipment change part storage units.
• Ensure documentation is completed in a timely and compliant manner to support audits and inspections.
• Develop an understanding of cGMP requirements & regulatory compliance standards.
• Ensure safe work practices are followed at all times and report any near misses to the Environmental Health & Safety (EHS) Department.

Continuous Improvement

• Contribute to continuous improvement initiatives across engineering and NPI processes.
• Support identification of process inefficiencies and assist in implementing practical improvements.
• Help standardise documentation and project tracking tools where applicable.
• Participate in Lean or operational excellence initiatives where applicable.

Learning & Development

• Develop an understanding of the full equipment lifecycle within a Contract Development and Manufacturing Organisation environment, from URS through to PQ.
• Gain hands-on exposure to regulated engineering practices, including GMP, validation, and equipment qualification.
• Build knowledge of pharmaceutical packaging and device assembly equipment (e.g., labellers, cartoners, casepackers, PFS assembly).
• Learn from experienced Engineering Leads and cross-functional teams through active participation in project activities.
• Take ownership of personal development, supported by mentoring and structured learning opportunities.
• Complete structured training on assembly equipment, packaging equipment, vision systems, and serialisation.
• Develop core project management skills including planning, communication and risk awareness.
• Undertake additional tasks or ad hoc projects as required to meet business needs within the scope of the role.
• Travel on company business as required (vendor, supplier or customer-based).

Knowledge & Experience

• Essential:
• 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-motivation with a proactive approach to learning.

• Desirable:
• Internship, placement or work experience within pharmaceutical, biopharmaceutical, food or regulated manufacturing environment.
• Basic understanding of cGMP principles.
• Exposure to project management methodologies and electrical and mechanical equipment.
• Experience using project tracking tools ( e.g. MS Project, Smartsheet ).

• Skills & Aptitudes:
• Strong interpersonal skills.
• Eagerness to learn and develop professionally.
• Ability to manage multiple tasks in a structured manner.
• Problem‑solving © ability with a logi