- Site SME to lead the development of site statistical systems, to lead the training of engineering and quality personnel in the use of these systems and in supporting their subsequent use on site.
- Enable site engineers, chemists & scientists in designing and deploying systems to transform data into useful process information.
- Support the expansion of current business and introduction of new drug product platforms across the site from a statistical perspective.
- Lead statistical best practices across the site.
- Provide statistical guidance for method validations and method transfers in the areas of accuracy, precision, linearity, equivalence testing (TOST), power and sample size.
- Support major process engineering and/or quality investigations from a statistical perspective to ensure data is available to provide focused information as part of the problem-solving processes
- Support the roll out of statistical process control (SPC) across the manufacturing platforms to promote equipment and product reliability.
- Evaluate the statistical methods and procedures used to obtain data to ensure validity, applicability, efficiency, and accuracy
- Analyse and interpret statistical data to identify significant differences in relationships among sources of information, e.g. use statistical tools to demonstrate comparability for process transfers.
- Develop and test experimental designs, sampling techniques, sampling plans and analytical methods
- Examine theories, such as those of probability and inference, to discover mathematical bases for new or improved methods of obtaining and evaluating numerical data.
- Deliver statistical training to engineers/scientists/quality personnel, specifically in the use of Minitab and JMP statistical software.
- Master’s, or PhD degree in Statistics, Biostatistics or Applied Maths.
- Minimum of 2 years prior work experience in Statistics for candidates with a Bachelor’s Degree.
- Excellent understanding of the applications of statistics in a manufacturing environment.
- Excellent problem solving and data analytical skills.
- Experienced user of statistical analysis packages, particularly Minitab and JMP.
- Strong influencing, communication and interpersonal skills.
- Strong ability to coach and mentor others across departments.
- Flexible with the ability to prioritise work in a dynamic environment.
- Familiar with regulatory statistical expectations.
- Effective change agent and ability to manage resistance to change.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100