Manufacturing Engineer, Inspection - Operations
AstraZeneca

West Chester, Ohio

This job has expired.


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

Monday-Friday Day Shift Role

The Manufacturing Engineer, Inspection is responsible for ensuring one technical process exists within the PET/Facility. This includes equipment, materials, process, and procedures with applicable validation. Leads improvement initiatives as the technical expert and acts as the first line of support for all project related work.Responsible for maintaining a strong relationship with Technical Operations and Quality areas, as well as, collaborating within the PET/Facility and with other PET Engineers. Serves as the single point of contact for all technical issues.

What you'll do:

  • Ensures there is 1 technical process with centerlines, critical process parameters, material fit for use, and operating procedures are clear and delivers a capable process.
  • Leads the following continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability and waste reduction for improvement of automated pharmaceutical manufacturing equipment.
  • Ensures success criteria for technology transfer and validation is clear and the process is capable for the merge into the PET/Facility process.
  • Generates a variety of URS, FAT, SAT, commissioning and IQ/OQ/PQ protocols/ reports.
  • Coordinate and support PET's/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies and obsolescence. Manages life cycle of assets.
  • Maintain external technical relationships and collaborates with equipment and material suppliers.
  • Identify, develop, generate and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations.
  • Perform and maintain risk management activities for new and existing processes / equipment.
  • Initiate deviations and performs/facilitates the technical investigations and assessment of impacts.


Essential for the role:
  • BS degree required in Engineering, or related science.
  • Training or experience in the applicable following technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical trouble shooting, aseptic/controlled environment, unit operations, formulation, packaging, process validation, cleaning validation, technology transfer, change control, applied statistics.
  • Proficiency in at least one of the following disciplines: automation/ controls, aseptic/packaging equipment, process/materials, maintenance, validation.


Desirable for the role:
  • Strong verbal and written communication skills.
  • Proven ability to work effectively in a team environment.
  • Ability to generate and interpret technical documents.
  • Experience managing external technical relationships.
  • Strong mechanical/technical aptitude.


Why AstraZeneca?

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:

LinkedIn https://www.linkedin.com/company/1603/

Facebook https://www.facebook.com/astrazenecacareers/

Instagram https://www.instagram.com/astrazeneca/?hl=en

About Operations https://www.youtube.com/watch?v=gak5Ham8oUw


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