Manufacturing Associate II

This is what you will do:

The Drug Product (DP) Manufacturing Associate will be a key member in supporting the execution of operational readiness at the Alexion Athlone Manufacturing Facility. The Manufacturing Associate will be an SME in a number of unit operations throughout the Fill Finish manufacturing process and will be responsible for execution of batch operations as per standard operating procedures under limited supervision.

You will be responsible for:

• Operate manufacturing equipment and instruments
• Complete assigned tasks in a timely manner
• Conduct daily activities in an organized, efficient manner
• Perform simple, routine, complex, and critical operations
• Troubleshoot equipment issues, when necessary
• Ensure process equipment is appropriately maintained for operation
• Perform and document operations in accordance with cGMP’s
• Implement equipment qualification protocols and validation protocols
• Routinely draft/ create and revise standard operating procedures, manufacturing batch records and other documents as required
• Recognize, initiate process deviations and perform deviation investigations and closure
• Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
• Adopt the Skills You'll Use Every Day at Alexion
• Maintain training compliance and train other staff
• Communicate effectively, written and verbal
• Ensure a safe working environment for all staff
• Plan daily activities and schedule operations
• Interact with other departments
• Aseptic Filling with RABS in grade B background
• Compounding / Formulation of products
• Sterile Filling of vials / syringes using Isolator
• Visual Inspection of finished product.
• Cleaning and Sanitation of equipment
• Operation of Parts washers and Autoclaves
• CIP /SIP of Vessels.
• Support regulatory audits
• Support all new product/process introductions on site.
• Perform data collection, compilation, and statistical analysis
• Interact with vendors and outside resources
• Complete assigned projects
• Be the shift lead if required, providing instruction to the team
• Troubleshoot and resolve operational problems during processing
• Represent Manufacturing in cross functional initiatives and meetings
• Monitor and evaluate process trends and recommend and implement continuous improvement strategies as appropriate
• Handle multiple projects independently
• Plan and implement complex changes
• Perform Environmental monitoring as required.
• Technical authority for entire area(s)
• Interact independently with regulatory agencies
• Develop and provide training on complex manufacturing processes
• Perform Manufacturing review and approval of critical documents
• Develop process validation protocols
• Maintain good housekeeping and clean and sanitize classified areas as required.
• Analyze complex problems and resolve and implement solutions

You will need to have:

• Able to work within and adapt to complex electronic systems such as SAP and EQV
• Able to read, write and converse in English
• Have good working knowledge of MS Excel and Word
• Ability to work in an intense, fast-paced work environment
• Ability to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously
• Ability to work independently and as part of a team
• More than 2 years’ experience in a cGMP biopharmaceutical manufacturing environment

We would prefer for you to have:

• BA/BSc in a scientific discipline or equivalent experience.

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.