Job Title:  Senior EO Commissioning Manager, EMEA-APAC

Position Summary

We are looking for a Senior EO Commissioning Manager, EMEA-APAC to join our team based in Calcinate (BG). He/she will plan and coordinate the execution of all technical activities required for commissioning and recommissioning of all new and existing EO equipment/chambers and ancillary areas; he/she will ensure Customer qualification activities and coordinate the timely calibration and verification of all ancillary equipment pertaining to EO validations. He/she will manage stocks, verifications, and calibration of dataloggers.

Duties

• Plans and manages all technical activities required for the successful commissioning of all new and existing EO equipment and ancillary areas.

• Liaises with key stakeholders to agree commissioning schedule, coordinates cycles, documents protocol, reviews cycle report, analyses data and documents report.

• Provides documentation, audit support and audit facilitation during Customer and regulatory audits.

• Conducts all work activities in compliance with STERIS Quality Management System, GDP, GMP ISO11135,

and ISO13485 regulatory requirements.

• Provides onsite training in the use of dedicated datalogger software

• Provides Technical onsite support in troubleshooting any issues

• Collaborates with software/hardware provider to resolve any issues

• Manages stock of data loggers, orders sufficient quantities to allow for attrition.

• Organises and coordinates the calibration of datalogger hardware.

• Actively supports STERIS’ ongoing continuous improvement and 5S initiatives, participates in/leads ongoing CI projects within the EO Technical department.

• Implements effective corrective actions to prevent non-compliances and/or reoccurrence of non-conformances

Duties - cont'd

• Collaborates and Supports Customers throughout all stages of their qualification project to document protocol, coordinate cycles provide batch records, analyse data, document report to complete qualification within agreed timeframe.

• Takes swift action if there is any non-conformance to cycle and ensures appropriate corrective action is

taken

• Provides support and facilitation as required to the Quality department during internal, Customer and regulatory audits.

• Support EO Technical Manager in tasks pertaining to the maintenance of site QMS, e.g. technical review and advice of NCs (RCA, Corrective Action), Change control

• Reviews and updates local procedures and processes to ensure compliance with Global work instructions.

• Adapts work practices to achieve EMEA system harmonisation and STERIS initiatives

• Prepares for, supports and facilitates internal audits and external audits conducted by Customers, notified

bodies and Regulatory Agencies.

• Conducts internal audits of the quality management system, documents and reports audit findings and

recommendations for improvement.

• Consistently generates paperwork and documentation in compliance with quality system requirements

• Aware of Health and safety requirements, follows safety policies and procedures and promptly reports any risks or observed breeches to the health and safety representatives.

Education Degree

Required Experience

• A minimum of 3 years industrial experience in EO sterilisation with comprehensive working knowledge of quality standards, process validation and Microbiological/chemical testing associated with the EO sterilisation process.
• Demonstrates solid proficiency and understanding of ISO11135 and other ISO standards relating to the EO sterilization of medical devices
• 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, ISO11138 series, etc.)

Skills

• Excellent project management and organisational skills
• Strong team leadership & management skills
• Ability to adapt to changing duties and responsibilities
• Proficiency Knowledge of English

Additional Information

We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status,  sex, sexual orientation, gender identity, genetic information, and any other category protected by state or local law.