API Technician (Shift based) - APICOM

API Manufacturing Operation Technician (shift Based) - APICOM

AstraZeneca/Alexion Campus

College Park, Dublin

Full Time, Permanent (shift based)

Close date: 20th October 2024

“Make a meaningful impact on people’s lives with life-changing medicines”

From research laboratories to manufacturing at scale, AstraZeneca are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines, from patients and their families to all of us in society!

Join the team where everyone feels a personal connection to the people that we impact.

The manufacture of small molecule Active Pharmaceutical Ingredients (APIs) is changing, especially with the ever-increasing complexity of products in our pipeline.
The ambition of shorter development times, lower commercial volumes, and increased focus on delivering carbon zero processes, increases demand towards approach innovation. In response, we are investing in an API Commercialisation (APICOM) facility built on our AstraZeneca/Alexion Dublin Manufacturing Campus in Ireland. This flexible, pioneering facility will manufacture low volume, high value, high potency APIs for late phase clinical, launch and early commercial supply using both batch and continuous manufacturing technology.

This will be a shift position and the type of shift is subject to change to meet business requirements. ERT membership will be included as a core responsibility.

This is what you will do:

As a member of the APICOM Operations team reporting to the Shift Leader/Technologist you’ll carry out multi-stage cGMP active pharmaceutical ingredient (API) manufacturing processes utilising reaction vessels from 50Ltr to 6300ltrs in compliance with AstraZeneca EHS, GMP, and specific product standards.

Duties include:

• Complete all relevant task-based documentation to meet EHS, GMP and standards, tasks such as initial material checks, charging/discharging and pack-off to equipment cleaning (pre and post manufacturing).
• Operating and cleaning process equipment according to standard operating procedures (SOPs)
• Complete all documentation following ALCOA+ principles.
• Closely monitor the operation of the plant and process both in the field and from the plant control system to ensure compliance with the process requirements.
• Set up routing panels for production, change over and cleans Manufacturing equipment to enable the smooth running of the plant.
• Charge powder and solvents reagents locally and from external tank farms.
• Perform sampling and testing activities throughout manufacturing process.
• Perform Cleaning and swabbing of all process equipment.
• Perform and document the results of all equipment cleaning sampling and inspections.
• Actively participate in any QMS record execution (deviations, investigations, etc) and support effective CAPA creation and closure.
• Provide operational input at capacity planning meetings such as processing risk assessments.
• Be active member of site Tier and Escalation processes
  

You will need to have:

• Applicants should be educated to a minimum of leaving certificate /relevant trade.
• Previous API experience is a distinct advantage.
• GMP and regulatory knowledge/awareness
• Excellent team player with problem solving skills who thrives in a collaborative team environment.
• Excellent Documentation Practices and Computer skills
• Lean awareness.
• Strong safety attitude and approach to training/workload timely completion

Desirable:

• Previous start up experience
• Documentation generation (drafting initial SOPs, MBR, LIMS sampling plans etc)
• Familiar with manufacturing process systems e.g. Delta V
• Lean qualification.
• Familiar with Electronic batch records.
• Experience of investigations and CAPAs and change controls.
• Experience of Tank farm operations.
• Excellent IT skills (excel, word, powerpoint etc)
• Aptitude for mechanical equipment operations.
• Awareness and understanding of process equipment and TPM.

Why AstraZeneca?

At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and fuel your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare!

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.