Job Description
We are seeking a Compliance Engineer to join our Engineering Department at our Carlow site, supporting operations in a GMP and Sterile Environment. This role is essential for ensuring compliance, safety, and reliable product supply. Key responsibilities include generating and expediting the review of Manufacturing GMP documentation such as deviation reports (QNs) and corrective and preventative actions (CAPAs), supporting global audit readiness, and participating in audits. The Compliance Engineer will also author, edit, and review controlled documents, collaborate within cross-functional teams to solve problems using Root Cause Analysis (RCA) methodologies, and ensure timely completion of documentation to maintain compliance with regulatory requirements.
What you will do:
1. Direct and lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective actions.
2. Preparation and analysis of Engineering metrics reports to trend for improved operational efficiencies.
3. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOPs, SWIs, training documents, JSAs, PMs and change controls.
4. Accountable for leading investigation analysis, identifying true root cause, identifying gaps and actions to close gaps. Collaborate with Engineering colleagues and other departments particularly IPT, Quality, EHS, Technical Engineering in completion of tasks.
5. Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned.
6. Support Audit Readiness activities.
What skills you will need:
1. Diploma or higher preferred, ideally in a related discipline.
2. Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting.
3. Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment.
4. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
5. Report, standards, policy writing skills.
6. Sterile filling processes and equipment experience preferred.
7. Proficiency in Microsoft Office and job-related computer applications.
8. Lean Six Sigma Methodology experience.
9. Effective time management and multi-tasking skills.
10. Proven organizational skills.
11. Excellent attention to detail.
At our company, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from Ireland to the world.
Employee Status: Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements: Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date: 12/26/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R322486
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