Validation Engineer

Position Summary

• Manages Customer Validations ensuring that all validation activities are carried out in compliance with Customer requirements, STERIS policies & procedures, ISO 11135, and ISO 13485, relevant international standards, directives, and regulations.
• Establishes strong Customer relations and provides exceptional Customer service to ensure Customer qualification requirements are met or exceeded throughout all stages of the validation.
• Proactively supports their direct Supervisor to successfully achieve departmental and site objectives and undertake assigned projects.
• Adopts positive cross functional relations. Liaises with quality, operations planning, laboratory and Customer Service to coordinate and progress Customer validations and projects. 
• Collaborates with EO Tech Team to support the establishment of best practice approach through knowledge sharing and providing recommendation for EO TechTeam harmonization.

Provides Customer Support & Technical Expertise (30%)

• Applies knowledge and technical expertise to make informed decisions and ensure best practice.
• Collaborates with Customers and provides technical input and recommendations to ensure all aspects of Customer validation requirements are fully considered and can be facilitated.
• Collaborates with Customers throughout all stages of their Validation projects to establish cycle process parameters in line with SEO and in compliance with ISO 11135.  
• Liaises with Customers throughout all stages of their validation project, generates and reviews validation protocols, reports and CSPs etc. establishes cycle process parameters in compliance with ISO 11135 and coordinates validation cycles within agreed timelines.
• Seeks advice, support, and input from EO Tech Team, Supervisor or Manager when needed to establish best practice approach. 
• Assists in educating and promoting technical solution offering to Customers. 
• Collaborates with direct Supervisor to achieve STERIS goals and objectives. 
• Actively participates in the exchange of ideas, identifies opportunities for improvement and implements appropriate solutions in line with best practice.

Day to Day Activities (30%)

• With support of direct Supervisor /SVE, manages Customer Validations and all associated documentation in compliance with STERIS Quality Management System, ISO 11135, ISO 13485 and FDA regulatory requirements while adhering to GMP and GDP requirement. 
• Performs according to the guidelines outlined in the STERIS Code of Business Conduct.  Supports STERIS AST business imperatives of Safety, Quality, Customer Focus, Innovation, Sustainability and Lean.
• Collaborates with all STERIS employees, Customers, auditors, and visitors to the site in a professional, constructive, and respectful manner.  Encourages open communication providing timely and accurate responses.
• Sets and agrees annual GPS performance objectives with direct Supervisor.  Actively participates in performance management reviews in line with STERIS corporate requirements and timelines.
• Complies with Health and safety polices & procedures, reports any concerns, potential risks or hazards to the Health and Safety representative so appropriate action can be taken.
• With support of direct Supervisor /SVE, collaborates with quality, operations, planning, laboratory, and Customer service to coordinate and progress Customer validations and projects in a timely manner from initiation to completion. 
• Actively participates in project Teams and leads projects agreed with direct Supervisor.
• Other site-specific duties and/or additional responsibilities as defined by direct Supervisor.

EO Technical Support and collaboration (15%)

• Supports harmonization and sharing of best practice within the EO Tech Team and across EMEA APAC region to achieve common objectives. 
• Complies with and supports their direct Supervisor with the implementation of local and global technical procedures and work instructions applicable to EO The Team.
• Collaborates and provides technical support to Customers, regularly interacts with Customers to ensure validation expectations are being met.
• Supports line manager/SVE in Customer meetings and business reviews when required.
• Shares technical expertise and knowledge.  Provides input and makes recommendations to ensure best practice approach is employed.
• Provides input and review on local and global work instruction and procedures to ensure alignment and adherence can be achieved.  

Performance Qualification, annual requalification and calibration/verification of dataloggers (5%)

Where applicable to the role or EO Technical department, with support of direct Supervisor /SVE.

• Assists with the launching, downloading, analysis, registration, verification, and calibration of data loggers to ensure sufficient stock of dataloggers are available to support ongoing validation requirements.
• Coordinates the calibration and maintenance of EO Technical related equipment to ensure calibration is maintained within date and equipment operates as intended.
• Schedules, documents and coordinates commissioning and recommissioning of assigned sterilisation chambers.

Continuous Improvement (5%)

• Actively participates in STERIS ongoing 5S, lean and continuous improvement initiatives.  Supports the TechTeam in identifying and implementing improvement initiatives.
• Identifies lean and continuous improvement opportunities and where feasible initiates or supports plan to implement improvement.

Technology development and Innovation (5%)

• Promotes the advancement of the STERIS SEO program through activities such as Cycle Calculation and/or Parametric Release.
• Educates Customers and recommends/promotes suitable technical solution offering with support of direct Supervisor /SVE.
• Supports EO focused R&D initiatives and provides support, technical input or expertise as required.

Training and Development (5%)

• Manages their individual training and development, identifies training and development opportunities, maintains professional skills and knowledge by attending training and development sessions. 
• Documents and files training records and certifications.
• Maintains professional skills, knowledge and abilities by attending education workshops, reviewing professional publications and participating in professional forums.

EO Regulatory Compliance (5%)

• Provides audit support and facilitation as required to the Quality department during internal, Customer and regulatory audits. 
• Addresses auditor queries and where necessary interacts directly with auditor with support direct Supervisor /SVE.
• Supports direct Supervisor in the close out of audit findings and recommendations pertaining to EO TechTeam.
• Supports root cause investigations and implementation of appropriate corrective and preventative actions in conjunction with the Quality Manager and site EO TechTeam.

Where required and with support of direct Supervisor /SVE.

• Initiates investigations for non-conforming qualification cycles.  In partnership with direct Supervisor and Site Quality Manager identifies, initiates, and implements effective corrective and preventative actions.
• Conducts internal audits of the quality management system, identifies, documents and reports audit findings, observations, recommendations for improvement or non-conformances. 
• In compliance with STERIS Quality Management system implements and manages change as per change control procedure.

Education Degree

Required Experience

1. Diploma/Degree in life-science or Engineering with a minimum of 1 years industrial experience with knowledge of ISO13485, process validation and Microbiological/chemical testing.   Knowledge of EO sterilisation process and ISO 11135 desirable.

2. In lieu of meeting the minimum educational requirement applicants with a minimum of 4 years industrial experience preferably in EO sterilisation, demonstrating strong technical skills with comprehensive working knowledge of quality standards ISO11135 and ISO13485 process validation and Microbiological/chemical testing associated with the EO sterilisation process will be considered.    

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
4. Ability to work well with others.
5. Excellent organizing, analysing and math skills to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.
6. Ability to adapt to changing duties and responsibilities.
7. Normal hearing range sufficient to hear alarms, bells, horns, etc.

Specific Work Requirements

1. Knowledge of EO sterilization and validation in accordance with ISO11135
2. Strong technical witing, 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, ISO 11737-1, ISO11138 series, ISO11137 series, EN 1422)
6. Proficient in use of MS Office and statistical tools