We are seeking a Compliance Engineer to support our pharmaceutical facility in Carlow. This role offers an opportunity to work in a dynamic, compliance-driven environment within the pharmaceutical industry.
Role Overview
The Compliance Engineer will be responsible for ensuring compliance, safety, and operational efficiency within the Engineering Department in a GMP and sterile environment. This role 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
* Prepare and analyze engineering reports to improve operational efficiencies
* Write and review key documentation, including SOPs, SWIs, training materials, PMs, and change controls
* Collaborate with teams across IPT, Quality, EHS, and Technical Engineering
* Ensure compliance with global policies, cGMP, and regulatory requirements
Qualifications and Experience
* Prior experience in a GMP manufacturing environment (experience with sterile filling processes preferred)
* Strong technical knowledge of compliance regulations, including Irish, EU, and International codes and standards
* Excellent communication, documentation, and organizational skills
* Proficiency in Microsoft Office and job-related applications
* Experience with Lean Six Sigma methodologies is an advantage
The Ideal Candidate
We are looking for a highly skilled and experienced professional who can ensure compliance, safety, and operational efficiency within our Engineering Department. If you have a strong background in compliance regulations, excellent communication skills, and experience working in a GMP manufacturing environment, we encourage you to apply.