Aseptic Process SpecialistReq # JR - 032725 Location Dublin, Leinster Job Category Quality Control Date posted 01/15/2021
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Your role at Baxter:
A great opportunity has recently arisen for an Aseptic Process Specialist to join a small team, supporting our x2 Dublin sites based in Sandyford, D18 site & Deansgrange.
We are presently seeking an experienced individual who gets excited by challenges and can identify root causes, is passionate about fixing problems and can anticipate issues before they arise.
This role has a lot of visibility, immediate impact, and lots of opportunities for future growth. It will be a mix of Quality Systems, Self-Inspection, Regulatory audits, Metrics, Training, New Projects, Process Improvements which are all critical to our mission of saving and sustaining lives.
If you are looking for a place where you choose to work with talented and dynamic people whose primary focus is to save and sustain lives and your work values focus on speed, simplicity, courage and collaboration. Then we would love to hear from you.
In this role, some key factors include:
Provide technical expertise to the x2 Dublin sites on sterility assurance aspects regularly
Collaborate and work alongside Quality Management Team.
Ensure effective sterility assurance and environmental monitoring programmes are deployed in all Dublin Compounding Facilities, in compliance with current GMP and the Baxter global strategy.
Support on standardization of sterility assurance practices and identification/implementation of new technology for microbiological testing and environmental control.
Participate in the compounding site complaints investigation, Nonconformance and quality incidents investigation, act as technical approver.
Participates in the internal and external audit program – includes regulatory inspections and corporate / internal audits.
Provide technical support in interpretation of Microbial Identification and Environmental Monitoring data.
Provide technical support for the trending of EM and Microbiological data including setting of appropriate Alert limits
Carry out validation and experimental design studies.
Ensure all aseptic processing is of the highest standard and meets current regulatory and industry guidance and best practice
Plan, Develop, Implement and Manage a microbiological environmental and personnel monitoring program compliant with regulations and industry expectation.
We are looking for someone that has:
Degree in Microbiology
Proven experience in implementing environmental control programs and OOL investigations.
Roll up your sleeves and engage directly attitude
5 years’ experience of microbiology experience in an aseptic facility.
Experience in development, implementation and management of short, medium and long term microbiological environmental plans and activities
Experience in commissioning of new sterile facilities, conducting EMQ and extensive experience in media fill and aseptic processing.
The ability to communicate and work in a conscientious and inclusive way.
Develop a culture of continuous quality improvement
If you like the sound of the above role and if this role resonates with you, then we’d love to talk to you. Apply here so we can discuss it more with you.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.