Senior Automation Engineer - Operations
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
Our West Chester Supply Site is a very dynamic and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio. In addition to serving as the global COVID vaccine production site for AstraZeneca, the West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes, Respiratory, and Vaccines. Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world. We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able to bring your full self to work every day is at the core of AstraZeneca’s priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests. We also have a Great Place to Work Counsel, involving committees of employees who coordinate several activities related to community outreach, sustainability, health and wellness and social events.
The Senior Automation Engineer is a professional engineer with formal team leader responsibilities who plans and coordinates specialist engineering activities and is charged with managing project revenues over a portfolio of projects. Alternatively provides technical and project management support to colleagues in an area of expertise within the engineering function.
What you'll do:
- Manage the design, implementation, and support of site-wide process automation, supervisory control, and data acquisition (SCADA) solutions. This could include but is not limited to programming and implementing new PLC/HMI code, changing existing PLC/HMI code and monitoring backups for data integrity and compliance.
- Support the configuration, administration, maintenance and continuous improvement activities for the site’s Manufacturing Execution Systems (MES).
- Conduct troubleshooting activities and train others on systems, software, equipment, machines, procedures, and/or processes.
- Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements.
- Review and approve documentation needed for qualification of equipment and processes.
- Write, review, and revise SOPs (Standard Operating Procedures) for maintenance of equipment, systems, and/or facilities.
- Author, review and approve change controls and document revisions. Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, etc.
- Ensure proper documentation practices during maintenance processes.
- Assess and implement improvements in productivity, waste generation, quality and cost, and assist process engineering and managers with improvement projects.
- Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area. Conduct presentations (other than training) for different audiences.
- Lead and coordinate investigations and studies with little supervision and close out deviations, CAPAs, and/or pAFCAs as needed.
- Interact with regulatory agency personnel during audits and inspections.
- Assist with executing validation protocols for processes, equipment, packaging, and/or cleaning.
- Provide 24/7 "on-call" support to others.
Required for the role:
- Bachelor’s degree required in Engineering, Computer Science or related discipline
- 5-7 years of experience supporting manufacturing operations in a regulated or cGMP environment
- Experience with Allen Bradley, Siemens, Emerson (Formerly GE) or B&R PLC platforms
- Experience with Allen Bradley, Wonderware, or Siemens SCADA platforms
- Ability to travel up to 5% (approximate)
Desirable for the role:
- Experience with Proficy Plant Applications, Historian and Real-Time Information Portal
- Knowledge of GAMP 5
- Experience of S88 and ISA standards
- Knowledge of change control, validation and qualification principles
Internal/External Contacts & Customers:
- PET Engineers
- Facilities and Engineering
- Quality Assurance
- External Regulators and Vendors
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
Find out more on Social Media:
About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.