Lead Technician, Bulk - Operations
AstraZenecaUs - west chester - ohUpdate time: August 6,2021
Job Description

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 Lead Technician is a direct labor position reporting to a Process Execution Team Process Facilitator on the Manufacturing floor, which supports Bulk/Diluent operations. The position requires operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment, performing in-process monitoring, product and environmental sampling, line clearances, OEE data collection and completing batch record entries in accordance with cGMPs. In addition, the Lead Technician will perform setup of equipment, execute training for Technicians, direct product and environmental sampling activities and perform batch reconciliation and accountabilities per cGMPs.

3rd shift (10:00pm-6:30am role) Mon-Fri

What you’ll do:

  • Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
  • Perform 5S activities and maintain organization of operating areas.
  • Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Be familiar with “Material Safety Data Sheets” for area chemicals.
  • Perform batch record and GMP documentation entries. Maintain records and/or logs as required in performance of job responsibilities. This will include mathematical computation where needed.
  • Responsible for outgoing quality level.
  • Working knowledge of automated and semi-automated inspection equipment.
  • Particulate inspection qualification for a pre-determined population of the team.
  • Schedule environmental sampling. Review environmental results and communicate trends to Process Execution Teams.
  • Sterile gowning qualification for sterile core operators. Sterile core operators will also understand aseptic behaviors, media fills including line interventions, and have a basic knowledge of viable and non-viable monitoring equipment. This will include performing sampling both inside and outside the sterile core.
  • Some overtime will be required with prior notice to support business needs.
  • Be able to start up and make minor adjustments to machinery.
  • Knowledge of light material handling equipment (non-motorized lifts).
  • Perform inventory control and reconciliation activities, which may require use of SAP as needed within the team.
  • Work with various printing devices including printing mats, ink-jet, and so on. Perform set-up of print and embossing blocks for lot information and expiration dating.

Essential for the role:

  • High School diploma or GED required.
  • Minimum two years of experience in a pharmaceutical production environment or regulated GMP environment.
  • Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
  • Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.

Desired for the role:

  • Working knowledge of Microsoft applications, SAP, KRONOS, and Trackwise.
  • Experience working in a LEAN manufacturing environment.
  • Knowledge of cGMPs and FDA policies/procedures.

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

Date Posted

05-Aug-2021

Closing Date

09-Oct-2021

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 authorization and employment eligibility verification requirements.

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