Description:
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
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
- Execute 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
- 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 sanitize classified areas as required.
- Analyze complex problems and determine and implement solutions
You will need to have:
- Must be able to work within and adapt to complex electronic systems such as SAP and Trackwise
- Must be able to read, write and converse in English
- Must 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.