Senior Packaging Engineer

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

Job summary

DPS Group Global in Ireland seeks an experienced Packaging Line Subject Matter Expert to support a major capital project involving installation, commissioning, qualification and validation of automated packaging and device assembly lines in a regulated pharmaceutical environment.

The successful candidate will act as technical authority and end-user representative throughout the project lifecycle, providing leadership and oversight across design, FAT/SAT, installation, qualification, and

Qualifications

• Degree in Engineering or a related technical discipline.
• Significant experience supporting packaging operations in pharma/biotech/medical device.
• Proven track record delivering packaging line installations and qualifications.

Responsibilities

• Act as Packaging Line SME from design through operational handover.
• Represent business and end users in design reviews, vendor meetings and decisions.
• Provide technical oversight for automated packaging and device assembly line implementation.
• Review and approve equipment designs, URS, FDS and project docs.
• Support vendors and system integrators during build and testing phases.
• Lead or participate in FAT and SAT activities.
• Act as client technical representative for equipment acceptance and project sign-off.
• Support installation and commissioning on site.
• Provide input into qualification and validation strategies.
• Coordinate with Validation and Quality to meet GMP requirements.
• Review qualification docs including IQ, OQ, PQ.
• Troubleshoot technical issues during commissioning and validation.
• Ensure vision inspection systems meet project requirements.
• Assist in SOPs and training materials development.
• Participate in risk assessments and change control.

Skills

Packaging SME

Capital projects

GMP validation

Vendor liaison

FAT/SAT

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.

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.