Applied Medical

Sterilization Engineer

Category (Portal Searching) Engineering
Job Locations NL-Amersfoort

Overview

Applied-Medical-Logo-w-Tag_H_Teal_cropped

At Applied Medical, we are committed to make a meaningful, positive difference, each and every day. Within our European headquarters in Amersfoort (NL), we develop, manufacture and support the implementation of our advanced medical devices across Europe and the MENA region. Applied’s team members enjoy working in an environmentally friendly and international environment, in which people of diverse backgrounds are valued, challenged, and acknowledged. We support our team members by giving them opportunities of ongoing learning and education, possibilities to take part in community volunteering activities and a variety of onsite exercise classes and health activities.

 

If you are passionate about working in an organization that allows you to make decisions based upon what is right for the patient, customer, community and environment, Applied Medical is the place for you.

Job Description

Are you an engaging engineer with experience working in an environment where safety, quality, and customer satisfaction are high priorities? Consider joining our new team as Sterilization Engineer. In this position, you will be responsible for maintaining and compliance of ethylene oxide sterilization process including sterilization validation, re-qualification studies and routine process within Applied Medical. You will be reporting to the Sterilization Plant Manager. You also will work closely together with our Engineering, Production, Maintenance, Quality and Safety teams. 

 

Key Responsibilities

 

  • Review Ethylene Oxide (EO) sterilization batch records to ensure compliance
    with applicable SOPs and regulations
  • Review and evaluate quality investigations for operational issues related to
    sterilization collaboratively with supporting teams to ensure product efficacy and
    safety
  • Perform process risk assessments
  • Resolve and facilitate resolution of sterilization related non-conformances and audit findings including identifying causes to prevent re-occurrence
  • Maintain expertise in current industry regulations and evaluate engineering protocols related to product tests (bioburden and sterility), new raw materials,
    packaging components and vendor qualifications
  • Support development and evaluation of new components based on bioburden,
    packaging and functionality for adoption into EO sterilization product family
  • Work with technical team on for preventative maintenance procedures with an
    assigned process or area
  • Qualifying, maintaining an troubleshooting ethylene oxide sterilization system and associated equipment
  • Support the development and validation of new sterilization process (IQ, OQ &
    PQ, parametric requirements, PCD, DEO, SLR, cycle calculation etc.,) for
    existing and/or new products and/or in case of changes to the system
  • Assist in external/internal/supplier audits to assure compliance with 21 CFR and
    ISO 13485 under responsibility area
  • Perform qualification for sterilizer equipment and create/update sterilization parameter for equipment as required

Requirements

  • B.S Engineering or Physical Sciences (e.g. Microbiology, Chemistry, etc.)
  • Minimum of 2+ years of manufacturing industry experience
  • Strong technical writing skills are required. Knowledge of aseptic technique and
    general laboratory skill is also preferred
  • Ability to follow standard procedures and use best practices
  • Excellent English, both written and spoken
  • Work experience in an international environment is preferred
  • Previous experience in ethylene oxide sterilization or related field is preferred
  • Experienced in using of statistical techniques and sampling procedures
  • Experience with Minitab and corporate ERP systems is preferred

We Offer

  • Good remuneration package including pension and 27 vacation days
  • Travel allowance and health insurance benefits
  • Working from home option available
  • Opportunity for personal development and continuous learning
  • Education reimbursement program
  • Reimbursement of relocation expenses may apply
  • Informal and international work environment with over 35 nationalities
  • Teambuilding and volunteer opportunities
  • Onsite group exercise classes and health activities

Interested?


Would you like to be part of our expanding team? If the answer is yes, we'd love to get to know you and look forward to hearing from you!

For more information regarding our hiring process, click here. If you have any questions, feel free to contact us via recruitment-eu@appliedmedical.com or +31 (0)33 7548713.

 

Not the right job for you? Take a look at our other vacancies and follow us on LinkedIn.

 

As a healthcare company, it’s of the utmost importance to keep our teams safe and healthy in this ever-changing COVID-19 environment. We highly encourage our team members to get vaccinated to help protect each other, our families, our customers, and our visitors, as we work together to help end the pandemic.

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