Validation Manager

10 ago - Italia
Altro

Experteer Overview In this role you lead the site EO TechTeam to ensure EO validation activities meet customer requirements, STERIS policies, and international standards. You act as the region's senior SME on EO sterilization, guiding equipment and process qualification and cross-functional collaboration. You'll support quality, regulatory, and continuous improvement initiatives while shaping regional practice and customer education. This is a growth opportunity to influence site performance and regulatory compliance at scale.
Retribuzione / Benefits Direct EO TechTeam leadership and coordinate day‐to‐day activities
Support harmonization of policies/procedures across EMEA/APAC sites
Provide high‐level external customer support and education activities
Ensure technical procedures and work instructions are implemented and compliant
Support qualification activities and supplier technical assessments
Collaborate with Quality/Regulatory on document reviews and audits
Engage with customers to meet service levels and participate in business reviews
Oversee recruitment, training,



and performance management of EO TechTeam
Manage equipment qualification and requalification per STERIS procedures and standards
Maintain data logger systems and ensure calibration for validation activities
Represent STERIS in EO regulatory matters and support regulatory submissions
Promote EO-focused R&D; initiatives and cycle design/parametric release
Responsabilità 5+ years in industrial sterilization with deep knowledge of EO, steam, irradiation, VHP
Strong understanding of ISO11135 and related standards (EN1422, ISO11138, ISO11137, ISO10993-7)
Proficient in data analysis, statistics, and technical writing
Excellent communication in English
Ability to lead teams, manage performance, and drive continuous improvement
Experience with GDP and Good Documentation Practices
Proven ability to engage with customers and cross‐functional teams
Requisiti fondamentali corporate premio
salary transparency/equa

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