Manufacturing Associate 3

Overview

This is what you will do: At Alexion Athlone, we have a state of the art aspectic manufacturing facility delivering rare and ultra rare products to our patients. We are building our team to create a manufacturing culture of excellence in everything we do. We will deliver on time for our patients with the highest quality product.

The Manufacturing Associate V is a member of a high performing team responsible for executing production according to schedule using MCS automation, completing paper batch records, SAP materials consumption, routine maintenance checks and continuous improvement of the work processes and environment.

Responsibilities

• The Manufacturing Associate3 (MA3) (GCLB) will be trained and competent to independently perform all core production tasks in the areas of Formulation, Compounding, Pooling, Washing, Autoclaving, Sterilisation, Aspectic Filling, Visual Inspection and all ancillary tasks such as equipment preparation.
• Responsible for execution of all tasks according to SOPs and batch records associated with the preparation for and production of Alexion products in cGMP environment ensuring full attention to detail and excellent documentation skills as per ALCOA+ principles.
• Assist with the investigation of operations deviations through the QMS system, engaging with all relevant personnel and functions as appropriate.
• Assist with the training of colleagues in SOPs, process execution and equipment operation.
• Provide input into the creation and maintenance of area SOPs and batch records.
• Where necessary, assist in any Facility and Equipment start up and Validation activities. Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.
• Effective SME within said area.
• Ablility to anticipate and troubleshoot operational issues and interface effectively with MCS.
• Engage with stakeholders including Technical Services, QA, and Automation colleagues to resolve issues.
• Be a mentor and a trusted source of knowledge, and be able to effectively impart that information and knowledge to others.
• Be a positive example to others in all areas of EHS, GMP and productivity.
• Be able to act as designee if required to prepare and deliver shift handovers, reporting out to DP LT/TS/Eng.
• Lead and Own investigations/ Change controls if required.
• Respond to schedule changes to maintain supply.
• Demonstrate a Lean mindset and lead by example in this area.

You will need to have

• Must be able to work within and adapt to complex electronic systems such as process automation, SAP and Trackwise QMS investigation system.
• Must have in-depth knowledge of Vial/Syringe Filling manufacturing processes and their translation into documentation such as batch records and SOPs
• Must be familiar with Aseptic equipment and systems such as RABS, Isolators, glass washers, GIT’s, FIT’s, Capping, CIP&SIP of Vessels, VI machines and WFI systems.
• Working knowledge of the requirements of Grade A, B & C Manufacturing Environments.
• Knowledgeable of current Good Manufacturing Practices (cGMPs) and regulatory requirements.
• Must possess strong verbal and written communication skills
• Perform QMS deviations.
• Highlight any issues that arise in production and contact the relevant departments for support as required.
• Ability to work independently and as part of a team.
• Available to work shift
• More than 1 years experience in a cGMP Aseptic Filling manufacturing environment, or equivalent experience preferred.

Preferred

• BA/BS in a scientific discipline or equivalent experience preferred.

Note: The posting includes standard recruitment language regarding inclusive environment and accommodations.