Commissioning Engineer

Position Summary

We are looking for a Commissioning Engineer to join our Company.

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.
• Ensure Customer qualification activities are scheduled and performed within the required timeframe.
• Coordinate the timely calibration and verification of all ancillary equipment pertaining to EO validations.
• Manage stocks, verifications, and calibration of dataloggers.
• Subject matter expert in the use of dedicated datalogger hardware and software.

Duties

Operational Qualification and annual requalification of EO processing Equipment
• 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, manages activities, 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.

Subject matter expert in the use of dedicated datalogger software and hardware
• Provides onsite training in the use of dedicated datalogger software in compliance with local procedures.
• Provides Technical onsite support in troubleshooting any issues that may arise when using datalogger software or hardware.
• Collaborates with software/hardware provider to resolve any issues that cannot be resolved locally.
• Plans for and manages through change control process any required updates to the software or hardware, and where necessary updates local procedures to reflect changes.
• Manages stock of data loggers, orders sufficient quantities to allow for attrition.
• Organises and coordinates the calibration of datalogger hardware.
• In partnership with EO Validation Supervisor and EO Technical Manager ensures that there is trained back-up in place to provide cover on dedicated tasks and responsibilities.

EO Technical expertise and Guidance
• Collaborates and proactively supports Validation Supervisor/EO Technical Manager to achieve STERIS goals.
• Actively supports STERIS’ ongoing continuous improvement and 5S initiatives, participates in/leads ongoing continuous improvement projects within the EO Technical department.
• Accepts additional responsibilities and project opportunities as assigned by the Validation Supervisor or EO Technical Manager.
• In partnership with the Validation Supervisor and Site Quality Manager identifies and implements effective corrective actions to prevent non-compliances and/or reoccurrence of non-conformances
• Contributes and performs in compliance with STERIS core values, STERIS code of business conduct and STERIS initiatives to meet corporate goals and objectives.

Customer Qualification’s
• Collaborates with Customers to agree timeline for completion of qualification activities.
• 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 so Customer can maintain routine production.

Duties - cont'd

EO Regulatory Compliance
• Provides support and facilitation as required to the Quality department during internal, Customer and regu-latory 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 if necessary, 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.
• Takes appropriate action on any assigned audit findings and implements appropriate corrective and preventative action.
• 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 and is audit ready at all times..

Education Degree

Required Experience

Degree in life-science subject, preferably microbiology. 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

Specific Work Requirements

1. Knowledge of EO sterilization and validation in accordance with ISO11135
2. Strong technical writing, scientific writing, and problem-solving skills
3. Sound understanding of research methodologies
4. Ability to complete statistical and data analysis
5. Working knowledge of other relevant ISO standards and guidance documents (ISO10993 7, ISO11138 series, etc.)
6. Proficient in use of MS Office and statistical tools
7. Ability to work autonomously
8. Strong team leadership & management skills
9. Ability to adapt to changing duties and responsibilities.

Specific Work Preferences

1. Ability to effectively read, write and verbally communicate in English.
2. Ability to work under general direction of a supervisor or Manager
3. Ability to work autonomously and to work well with others.
4. Excellent project management and organisational skills. Be able to take the Lead in project and make informed decisions when needed or collaborate with key stakeholders to reach consensus.
5. Excellent organizing, analysing and math skills to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.

Specific Skills

1  EO Process & Technical Knowledge - Demonstrates solid proficiency and understanding of ISO11135 and other ISO standards relating to the EO sterilization of medical devices
2. Initiative/Leadership - Self-starter takes charge with little direction, seeks clarification if unsure of direction Proactively voices ideas, opinions, and recommendations, in a constructive way
3. Customer Focus - Demonstrate a “Customer first, always” mind set and a passion for serving each Customer by listening and identifying their needs.
4. Teamwork - Builds constructive and effective relationships and effectively manages through conflict while maintaining relationships.
5. Communication - Clear, concise communicator who can clearly express opinions and ideas while maintaining trust and credibility.
6. Job Knowledge/Business Acumen - Demonstrates solid proficiency in job function and understands how his/her position impacts the organization

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.