Document Controller

Desired Skills: MS Office Suite,Engineering,Science,GMP,Document Controller,Documentation

The Role

PE Global are recruiting for a Document Controller for our biopharmaceutical client based in Dun Laoghaire, Dublin. This is an initial 12-month contract role, hybrid working options.

Job Responsibilities

• Maintain Smartsheet or equivalent trackers for Operational Readiness documentation (e.g., SOPs, TRNs, APPXs, FMEAs, MES recipes).
• Ensure version control, metadata accuracy, and timely approvals in CDOCS and other ADL systems.
• Prepare documentation packages for Go/No-Go readiness reviews and regulatory inspections.
• Own and update Operational Readiness document tracker (e.g., ADL1X Doc Tracker) to provide high-level visibility of scope and progress.
• Monitor readiness deliverables linked to milestones (e.g., FAT, SAT, PPQ, media fill readiness) and escalate delays.
• Liaise with functional leads (Manufacturing, QA, Validation, Automation, Supply Chain) to collect and verify documentation inputs.
• Support weekly Ops Readiness governance meetings with dashboards and gap reports.
• Collaborate with Training team to ensure SOPs and curricula are approved and scheduled.
• Coordinate with MES and Automation teams for recipe readiness and system documentation.
• Work closely with Validation to track protocol execution and approval status.
• Align documentation scope between Ops Readiness and Capital Projects to prevent duplication.
• Assist in preparing turnover packages for operational handover and Go-Live readiness.

Educations & Experience

• Bachelor’s degree in Science/ Engineering
• 3+ years in document control or readiness coordination within GMP manufacturing or large-scale projects.
• Familiarity with Operational Readiness frameworks and GMP documentation standards.
• Proficiency in Smartsheet, CDOCS, SharePoint, and Microsoft 365 tools.
• Preferred
• Knowledge of change control strategy and readiness governance processes.

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up-to-date CV aisling.oleary@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****