Job Description:
The role involves supporting the Engineering Department in a GMP and Sterile Environment.
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 SOPs, SWIs, training documents, JSAs, 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 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.
Requirements:
* 3+ years experience in a pharmaceutical or a highly regulated environment.
* Sc.Degree or other qualification in Science, Engineering or a related field.
* 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.
Company Information:
Working for {company}, you will be part of a team that values quality and compliance above all else.