Job Title: Compliance Engineer
Role Overview
The Compliance Engineer plays a crucial role in ensuring compliance, safety, and operational efficiency within the Engineering Department in a GMP and sterile environment. This involves leading investigations, analyzing engineering metrics, and supporting audit readiness activities while collaborating with cross-functional teams.
Key Responsibilities
* Lead deviations, failure analyses, and root cause investigations to identify and address issues promptly.
* Prepare and analyze engineering reports to improve operational efficiencies and drive continuous improvement.
* Write and review key documentation, including Standard Operating Procedures (SOPs), SWIs, training materials, PMs, and change controls.
* Collaborate with teams across IPT, Quality, EHS, and Technical Engineering to ensure seamless communication and coordination.
* Ensure compliance with global policies, cGMP, and regulatory requirements, staying up-to-date with changes and updates.
Qualifications and Experience
* Prior experience in a GMP manufacturing environment, preferably with sterile filling processes.
* Strong technical knowledge of compliance regulations, including Irish, EU, and International codes and standards.
* Excellent communication, documentation, and organizational skills to effectively interact with stakeholders.
* Proficiency in Microsoft Office and job-related applications to efficiently manage tasks and data.
* Experience with Lean Six Sigma methodologies is an advantage, but not required.