Senior Packaging Engineer

DPS Group Global; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

DPS Group Global is seeking an experienced Packaging Line Subject Matter Expert (SME) to support a major capital project in a regulated pharmaceutical manufacturing environment in Ireland. The role provides technical authority and end‑user representation for packaging systems through design, FAT/SAT, installation, qualification and handover.

You will collaborate with vendors, system integrators, and engineering, quality, validation and operations teams to ensure compliant, robust and efficient

Qualifications

• Engineering degree in a technical field.
• Significant experience as SME or technical lead on capital projects.
• Strong understanding of GMP and validation methodologies.
• Experience with packaging equipment and device assembly lines.
• Stakeholder management and effective communication.

Responsibilities

• Act as Packaging Line SME from design through to operational handover.
• Represent business and end users in design reviews, vendor meetings and project decisions.
• Provide technical oversight for implementation of new automated packaging and device assembly lines.
• Review and approve equipment designs, URS, FDS and project documentation.
• Support vendors and integrators during equipment build and testing phases.
• Lead or participate in FAT and SAT activities.
• Serve as client technical representative for equipment acceptance and project sign-off.
• Support installation and commissioning activities on site.
• Provide input into qualification/validation strategies.

Skills

Technical SME leadership

GMP compliance understanding

Vendor coordination

Project lifecycle

Validation knowledge

Education

Engineering degree

Job description

Position Summary

An experienced Packaging Line Subject Matter Expert (SME) is required to support the delivery of a major capital project involving the installation, commissioning, qualification and validation of new automated packaging and device assembly lines within a regulated pharmaceutical manufacturing environment.

Position Summary

An experienced Packaging Line Subject Matter Expert (SME) is required to support the delivery of a major capital project involving the installation, commissioning, qualification and validation of new automated packaging and device assembly lines within a regulated pharmaceutical manufacturing environment.

The successful candidate will act as the technical authority and end-user representative for the packaging systems throughout the project lifecycle. This role will provide leadership and oversight during design, equipment build, FAT/SAT, installation, commissioning, qualification, validation and operational handover activities.

The Packaging Line SME will work closely with equipment vendors, system integrators, engineering, quality, validation and operations teams to ensure the successful delivery of robust, compliant and efficient packaging operations.

Key Responsibilities

• Act as the Packaging Line Subject Matter Expert for the project from design through to operational handover.
• Represent the business and end users during design reviews, vendor meetings and project decision-making activities.
• Provide technical oversight for the implementation of new automated device assembly and packaging lines.
• Review and approve equipment designs, layouts, user requirement specifications (URS), functional design specifications (FDS) and associated project documentation.
• Support equipment vendors and system integrators during equipment build and testing phases.
• Lead or participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities.
• Act as the client technical representative for equipment acceptance and project sign-off.
• Support installation and commissioning activities on site.
• Provide technical input into equipment qualification and validation strategies.
• Coordinate with Validation and Quality teams to ensure all systems meet GMP and regulatory requirements.
• Review and approve qualification documentation including IQ, OQ and PQ protocols.
• Support troubleshooting and resolution of technical issues encountered during commissioning and validation.
• Ensure vision inspection systems are designed, tested and implemented in accordance with project requirements.
• Support development of SOPs, training materials and operational documentation.
• Participate in project risk assessments, FMEAs and change control activities.
• Ensure the project is delivered safely, on schedule and in compliance with company engineering standards.

Required Experience

• Degree qualification in Engineering or related technical discipline.
• Significant experience supporting packaging operations within the pharmaceutical, biotechnology or medical device industry.
• Proven experience delivering packaging line installation, commissioning and qualification projects.
• Strong understanding of automated packaging equipment and assembly systems.
• Experience acting as an SME, technical lead or equipment owner on capital projects.
• Demonstrated experience working with equipment vendors and system integrators.
• Experience supporting FAT, SAT, commissioning and equipment startup activities.
• Strong knowledge of GMP requirements and validation methodologies.
• Experience with qualification activities including IQ/OQ/PQ.
• Familiarity with change control, deviation management and risk assessment processes.
• Excellent stakeholder management and communication skills.