Manufacturing Associate II

Location: Monksland, Athlone

Competitive salary and benefits

Contract: Permanent Contract

Shifts Initially:

Day/Evening 16/5 Shifts (8 hr shift x2 shifts per day x5 days Rotation) 37.5 hours per week - Monday to Friday 07:00-15:15 - 14:45-23:00

Moving to:

4 Cycle, 12.25 hr. Shift, 41.1 hr. Average Work Week (24x7 Operations) in Q2 2027

Are you ready to make a difference in the world of biopharmaceuticals? As a Drug Product Manufacturing Associate II at the Alexion Athlone Manufacturing Facility, you'll play a pivotal role in ensuring operational readiness and excellence. You'll be an expert in various unit operations throughout the Fill Finish manufacturing process, performing batch operations with precision and under limited supervision. Dive into a dynamic environment where your skills will contribute to life-changing medicines.

Accountabilities:

• Operate manufacturing equipment and instruments

• Complete assigned tasks in a timely manner

• Conduct daily activities in an organised, 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

• Complete equipment qualification protocols and validation protocols

• Routinely draft/develop and revise standard operating procedures, manufacturing batch records, and other documents as required

• Recognise, 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

• Embrace Alexion Core Competencies

• 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

• Manage multiple projects independently

• Plan and implement complex changes

• Perform Environmental monitoring as required

• Technical expert 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 sanitise classified areas as required

• Analyse complex problems and determine and implement solutions

Essential Skills/Experience:

• 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 solid understanding 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

• 2 years + experience in a cGMP biopharmaceutical manufacturing environment

Desirable Skills/Experience:

• BA/BSc in a scientific field or equivalent experience

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why this essential worker role works onsite. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you'll find an environment where innovation thrives. Our patient-driven culture encourages exploration of new ideas that have a profound impact on lives. Diversity is valued here, fostering an inclusive atmosphere where life-changing ideas can emerge from anywhere. We celebrate achievements together, ensuring kindness is integral to our ambition to succeed for those in need. Our commitment extends beyond our work, as we take pride in giving back to the communities we serve.

Ready to embark on this exciting journey? Apply now to join our team!

Date Posted

Closing Date