Aseptic Operations Engineer
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
At AbbVies Ballytivnan site in Co. Sligo one of our greatest strengths is our commitment to delivering life-changing products for our patients through manufacturing excellence in an aseptic environment.
Our focus in this area is key to our ongoing success and to support this we are expanding our expertise by building an Aseptic Subject Matter Expert (SME) team. We are now seeking a skilled and driven Aseptic Operations Engineer to join our growing site.
About the Role: As an Aseptic Operations Engineer and part of the Aseptic Operations function you will act as an Aseptic Manufacturing SME ensuring equipment cleanroom and utility systems are designed and operated according to AbbVie standards and best practices. Youll collaborate with cross-functional site colleagues and help foster a high-performance culture focused on continuous improvement and aseptic excellence.
Key Responsibilities:
- Serve as Subject Matter Expert for all equipment cleanroom and utility systems supporting aseptic manufacturing.
- Ensure all related systems are compliant with safety environmental aseptic GMP and regulatory requirements as well as Network Best Practice.
- Support operations through real-time monitoring of cleanroom and utility system performance and critical equipment cycles (e.g. CIP SIP VHP aseptic filling autoclaves lyophilization depyrogenation heat sterilization).
- Investigate and address automation alarms and proactively trend system performance developing action plans as needed.
- Partner with Quality Operations MQA and Aseptic mentors to deliver safe quality and timely product batches assuring sterility at every step.
- Participate in troubleshooting and investigations for equipment cleanroom and utility events working to establish root cause and support CAPA.
- Drive continuous improvement by assessing and implementing new regulations best practices and process enhancements within Aseptic Manufacturing Engineering.
- Provide key input into the design of engineering systems; ensure alignment with AbbVie standards and lead projects related to equipment and utility changes.
- Approve preventative maintenance strategies rank alarms by criticality and ensure robust change control and risk management procedures.
- Act as SME during regulatory audits and actively support contamination control and sterility assurance initiatives.
- Promote a speak-up high-performance culture through leadership engagement and participation in manufacturing and testing GEMBAs.
Qualifications :
- Third Level Degree in an Engineering or equivalent discipline.
- 3 Years of experience in a GMP Environment with 1 years of experience in support of Aseptic Manufacturing
- Strong knowledge of Regulatory Requirements
- Project Management experience
- Excellent communication skills
Additional Information :
What We Offer:
- The opportunity to work in a world-class innovative and patient-focused environment.
- A chance to drive impactful change and be recognized as an engineering SME within a global biologics leader.
- Professional growth and development through collaboration with industry experts and ongoing training.
Ready to help us set new standards in Aseptic Manufacturing Join our team and help shape the future at AbbVie Ballytivnan.
Apply today to start your journey with AbbVie!
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Change Management
- Software Deployment
- Cloud Infrastructure
- High Availability
- IaaS
- Firewall
- Linux
- Middleware
- Jboss
- Network Architecture
- Scripting
- Technical Support
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
