Senior Packaging Line SME — GMP Project Lead

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

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