Validation Technician

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

As a member of the EO TechTeam the Validation Technician works as directed by their direct Supervisor to support Customer EO qualifications in compliance with STERIS Quality Management System ISO11135 ISO13485 and FDA regulatory requirements while adhering to GMP and GDP supports their direct Supervisor to successfully achieve departmental goals and STERIS EO Technical Team in establishing strong functional and cross functional Customer relations and provides exceptional Customer service to ensure requirements of their role are being with EO Tech Team to support the establishment of best practice approach through knowledge and idea sharing.

Duties

Day-to-Day Activities (70%)

• Support Customer EO qualifications within the EO Technical department following supervisor guidance.
• Ensure all activities and documentation comply with STERIS Quality Management System ISO11135 ISO13485 FDA requirements and GMP / GDP standards.
• Review qualification batch records for compliance resolve queries with Operations promptly.
• Provide administrative support : filing and archiving qualification records and related documentation.
• Set annual performance objectives with supervisor and participate in performance reviews.
• Contribute to team projects and uphold STERIS Code of Business Conduct and business imperatives (Safety Quality Customer Focus Innovation Sustainability Lean).
• Collaborate professionally with colleagues customers auditors and visitors ensuring open and timely communication.
• Comply with Health & Safety policies report risks or hazards.
• Perform other site-specific duties as assigned.
• Where applicable : Manage dataloggers (launch provide to Operations download / analyze data verify / calibrate register).

EO Tech Team Support & Collaboration (15%)

• Review and provide input on local work instructions / procedures for alignment and adherence.
• Share knowledge to harmonize processes and promote best practices.
• Identify and implement improvement opportunities with supervisor approval.
• Collaborate closely with supervisor to meet role expectations and STERIS objectives.
• Seek guidance when needed and apply technical knowledge to support decision-making.

EO Regulatory Compliance (5%)

• Support audits (internal customer regulatory) and assist in closing findings related to EO Tech Team.
• Contribute to root cause investigations and corrective / preventive actions with Quality Manager and supervisor.
• Where applicable : Participate in internal audits document findings and recommend improvements.

Training and Development (5%)

• Manage personal training and development maintain skills through sessions and certifications.
• Document and file training records.

Continuous Improvement (5%)

• Actively participate in 5S Lean and continuous improvement initiatives.
• Identify and support implementation of improvement opportunities.

Education Degree

• Associates Degree
• Bachelors Degree

Required Experience & Competencies

• Professional Certificate or Diploma level qualification in Business Administration or Technical / Engineering. Working knowledge of ISO13485 ISO11135 and EO sterilisation knowledge desirable but not essential.
• Strong technical and problem-solving skills
• Excellent attention to detail displaying exceptional GDP and GMP.
• Proficient in use of MS Office with ability to complete data analysis using Microsoft excel
• Knowledge of EO sterilization and validation in accordance with ISO11135
• Working knowledge of other relevant ISO standards and guidance documents (ISO10993-7 ISO 11737-1 ISO11138 series ISO11137 series EN 1422)
• Ability to effectively read write and verbally communicate in English.
• Excellent organizing skills
• Ability to adapt to changing duties and responsibilities.

STERIS is an Equal Opportunity Employer

We are committed to equal employment opportunity 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 military or veteran status sex (including pregnancy childbirth and related medical conditions) sexual orientation gender identity genetic information and any other category protected by federal state or local law. We are not only committed to this policy by our status as a federal government contractor but also we are strongly bound by the principle of equal employment opportunity.

Required Experience :

IC

Key Skills

Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type :

Full Time

Experience :

years

Vacancy :

1