Senior Packaging Engineer

Arcadis; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Arcadis is seeking an experienced Packaging Line Subject Matter Expert to support a major capital project for automated packaging and device assembly lines in a regulated pharmaceutical environment. You will act as the technical authority and end-user representative across the project lifecycle, providing leadership in design, FAT/SAT, commissioning, qualification and handover.

The role requires strong SME capabilities, collaboration with vendors, system integrators and cross-functional teams,

Qualifications

• Significant experience with pharmaceutical/biotech packaging operations.
• Strong knowledge of GMP requirements and validation methodologies.
• Experience delivering packaging line installation, commissioning and qualification projects.

Responsibilities

• Act as Packaging Line SME from design through to operational handover.
• Represent business and end users during design reviews and vendor meetings.
• Provide technical oversight for automated packaging line implementation.
• Review and approve URS, FDS and related project documentation.

Skills

Packaging equipment

GMP

Project leadership

Vendor management

Validation

Education

Engineering degree

Job description

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.