Orion Group are currently recruiting a Compliance Engineer on behalf of our multinational biopharmaceutical client based in Carlow on an initial 11-month contract with potential to extend.
Responsible for supporting the Engineering Department in a GMP and Sterile Environment. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers.
Key Responsibilities:
* Direct and/lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective actions.
* Preparation and analysis of Engineering metrics reports to trend for improved operational efficiencies.
* Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP’s, SWI’s, training documents, JSA’s, PM's and change controls.
* 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.
* Required to comply with company 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.
* Support Audit Readiness activities.
* May be required to perform other duties as assigned.
Experience/Education:
* Diploma or higher preferred, ideally in a related discipline.
* Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting.
* Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment.
* Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
* Report, standards, policy writing skills required.
* Sterile filling processes and equipment experience preferred.
* Proficiency in Microsoft Office and job-related computer applications required.
* Lean Six Sigma Methodology experience desired.
* Good analytical skills and systems awareness, high level of data gathering, process mapping and financial.
* Knowledge of SOX Compliance.
* Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers.
* Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes the department supports.
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