Validation Manager
STERIS · Bergamo, Lombardia ·
Position Summary We are looking for a candidate that will join our team as a Validation Manager. Management of the site EO TechTeam, ensuring that all EO validation activities are carried out in accordance with Customer requirements, STERIS policies best practice sharing; training attention to detail.
Knowledge of EO sterilization and validation in accordance with ISO11135. Strong technical writing, scientific writing and problem‑solving skills. Sound understanding of research methodologies. Ability to complete statistical and data analysis.
Working knowledge of other relevant ISO standards and guidance documents (ISO10993‑7, ISO 11737‑1, ISO11138 series, ISO11137 series, EN 1422). Proficient in use of MS Office and statistical tools. Specific Work Preferences Ability to demonstrate mathematical and technical competence for problem solving.
Excellent organising and analysing skills with ability to determine organisational, Customer and regulatory problems and formulate corrective action plans. Proficient in use of MS Excel, MS Word, MS PowerPoint. Able to complete statistical and data analysis using statistical tools such as MS Excel.
Ability to adapt to changing duties and responsibilities. Academic knowledge of Quality Systems and working in a regulated environment. Academic knowledge of Good Documentation Practices (GDP). Normal hearing range sufficient to hear alarms, bells, horns, etc. Specific Skills EO Process