Senior EO Commissioning Manager, EMEA-APAC
at Steris
24050 Calcinate, Lombardia, Italy -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 11 Aug, 2024 | Not Specified | 12 May, 2024 | 3 year(s) or above | Data Analysis,Technical Writing,Regulatory Requirements,Scientific Writing,Management Skills,Corrective Actions,Industrial Experience,Process Validation,Medical Devices,Iso Standards,English,Validation,Team Leadership,Attrition,Continuous Improvement | No | No |
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Description:
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
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.
EDUCATION DEGREE
- Bachelor’s Degree in Biological Science
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
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-conformance
Responsibilities:
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.
REQUIREMENT SUMMARY
Min:3.0Max:8.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Biological science
Proficient
1
24050 Calcinate, Italy