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Compliance Engineer
1 month ago
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
1. Lead deviations, failure analyses, and root cause investigations
2. Prepare and analyze engineering reports to improve operational efficiencies
3. Write and review key documentation, including SOPs, SWIs, training materials, PMs, and change controls
4. Collaborate with teams across IPT, Quality, EHS, and Technical Engineering
5. Ensure compliance with global policies, cGMP, and regulatory requirements
Qualifications and Experience
1. Prior experience in a GMP manufacturing environment (experience with sterile filling processes preferred)
2. Strong technical knowledge of compliance regulations, including Irish, EU, and International codes and standards
3. Excellent communication, documentation, and organizational skills
4. Proficiency in Microsoft Office and job-related applications
5. Experience with Lean Six Sigma methodologies is an advantage
The Next Step for You
Should this position be of interest, please apply with an up-to-date CV to Jessica from Next Generation Recruitment or call us on the main line at 016629120.
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