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Graduate Sterility Assurance Scientist / Engineer

  • Job
    Full-time
    Entry Level
  • Science
    Engineering
  • Cork

AI generated summary

  • You should have a degree in Engineering or Science, good PC skills, communication abilities, GMP familiarity, and the capability to work both independently and in a team.
  • You will monitor sterilization equipment, lead process improvements, perform maintenance assessments, manage projects, troubleshoot sterilization processes, and ensure compliance with regulatory standards.

Requirements

  • Graduate in an Engineering or Science discipline
  • Good PC Skills and Computer literate.
  • Good communication and motivation skills.
  • Familiarity with working in a GMP environment.
  • Ability to both work alone and with a team.

Responsibilities

  • Monitoring performance of the sterilisation equipment to ensure any deterioration does not affect sterilisation performance.
  • Leading cross functional teams and working alone to execute upgrades, process improvements and projects related to the sterilisation process and equipment.
  • Co-ordinate/ perform equipment CIP & SIP studies.
  • Assessing planned and unplanned maintenance on the sterilisation equipment to ensure there has been no effect on sterilisation performance.
  • Preparation executions of URS, FDS, IQ, OQ, PQ protocols.
  • Project management of small to medium site specific capital projects through from conception, approval, planning to execution and validation. Management of and liaising with equipment vendors and contractors.
  • Trouble shooting providing continuous technical support on the sterilisation processes in conjunction with the maintenance, Validation, production and Quality Departments.
  • Ensure compliance with current technical, engineering and regulatory standards and guidelines.
  • Executions of re-qualification studies and reviews of qualification studies on Sterility Assurance equipment.
  • Engage with Trackwise software to perform investigations, deviations etc.

FAQs

What is the role of a Graduate Sterility Assurance Scientist/Engineer?

The role involves overseeing the sterilisation process from an engineering perspective, ensuring sterilisation equipment is maintained in a validated state, and applying rigorous change control.

What qualifications are required for this position?

A graduate degree in an Engineering or Science discipline is required.

Is experience in a GMP environment necessary for this role?

Familiarity with working in a GMP environment is required for this position.

What kind of skills are necessary for this role?

Candidates should possess good PC skills, communication and motivation skills, and the ability to work both independently and as part of a team.

What are some primary responsibilities of this role?

This role includes monitoring sterilisation equipment performance, coordinating maintenance studies, preparing qualification protocols, project management, troubleshooting processes, and ensuring compliance with regulatory standards.

Will the Graduate Sterility Assurance Scientist/Engineer work with other teams?

Yes, the position requires close coordination and cooperation with the Sterility Assurance Lead, Quality, Engineering, Operations, and Validation personnel.

Are there opportunities for upcoming projects or improvements in this role?

Yes, the role includes leading cross-functional teams to execute upgrades, process improvements, and manage small to medium site-specific capital projects.

Is relocation assistance provided for this position?

No, relocation assistance is not provided.

What competencies are valued for this role?

Competencies include being results-oriented, decision making, teamwork, flexibility, problem-solving ability, accountability, and strong communication skills.

What tools or software will I engage with in this position?

The role involves using Trackwise software to perform investigations and manage deviations.

Science & Healthcare
Industry
10,001+
Employees
1892
Founded Year

Mission & Purpose

Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE HealthCare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. We embrace a culture of respect, transparency, integrity and diversity and we work to create a world where healthcare has no limits.