Purpose
The Compliance Engineer will be responsible for supporting DMO Compliance activities at the single use multi-product biotech facility.
Responsibilities
Ensure permanent inspection readiness within the DMO team.
Support generation, review, and approval of CSA deliverables.
Provide ongoing compliance (GxP, Financial, Data Privacy) coaching and support to all team members.
Manage deployment of Global SDLC/CSA and IT Security policies and procedures.
Ensure supply of all compliance components required to deliver high quality product through tactical planning and execution of project and compliance deliverables, including change‑control, periodic reviews, performance monitoring, system administration, access administration, disaster recovery, deviations, incident problem management/investigations, CAPAs, audits, policy deployment, cyber security, data integrity, EHS, training, etc.
Ensure highest Quality, EHS & Compliance standards.
Active participation in the Tier process and proactively resolve issues.
Liaise with Compliance Engineers from other areas and support Site Quality Council and other site quality initiatives.
Coordinate AIT Change‑controls, EHS activities and EHS/Quality metrics.
Complete AIT Investigations, root‑cause analysis and CAPAs.
Strong project management skills to support project delivery and operational readiness.
At least 2 years experience in planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant.
A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11 and 21 CFR Part 11.
Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments).
Experience in PLC/SCADA/DCS systems.
Requirements
Preference for Lean Six Sigma Green Belt.
Desirable to have qualification in Project Management and Computer Validation.
Very strong collaboration, compliance and communication skills.
Desired Skills and Experience
2+ years CSV experience in biologics manufacturing.
Knowledge of EU GMP Annex 11, 21 CFR Part 11, Data Integrity.
Experience with PLC/SCADA/DCS systems.
Degree in Science/Engineering.
Strong project & compliance management skills.
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Manufacturing
Industry
Pharmaceutical Manufacturing
Location
Dunboyne, County Meath, Ireland
Salary: €39,474.00‑€79,618.00
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