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:
1. Operate manufacturing equipment and instruments
2. Complete assigned tasks in a timely manner
3. Conduct daily activities in an organized, efficient manner
4. Perform simple, routine, complex, and critical operations
5. Troubleshoot equipment issues, when necessary
6. Ensure process equipment is appropriately maintained for operation
7. Perform and document operations in accordance with cGMP’s
8. Implement equipment qualification protocols and validation protocols
9. Routinely draft/create and revise standard operating procedures, manufacturing batch records and other documents as required
10. Recognize, initiate process deviations and perform deviation investigations and closure
11. Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
12. Adopt the Skills You'll Use Every Day at Alexion
13. Maintain training compliance and train other staff
14. Communicate effectively, written and verbal
15. Ensure a safe working environment for all staff
16. Plan daily activities and schedule operations
17. Interact with other departments
18. Aseptic Filling with RABS in grade B background
19. Compounding / Formulation of products
20. Sterile Filling of vials / syringes using Isolator
21. Visual Inspection of finished product.
22. Cleaning and Sanitation of equipment
23. Operation of Parts washers and Autoclaves
24. CIP / SIP of Vessels.
25. Support regulatory audits
26. Support all new product/process introductions on site.
27. Perform data collection, compilation, and statistical analysis
28. Interact with vendors and outside resources
29. Complete assigned projects
30. Be the shift lead if required, providing instruction to the team
31. Troubleshoot and resolve operational problems during processing
32. Represent Manufacturing in cross functional initiatives and meetings
33. Monitor and evaluate process trends and recommend and implement continuous improvement strategies as appropriate
34. Handle multiple projects independently
35. Plan and implement complex changes
36. Perform Environmental monitoring as required.
37. Technical authority for entire area(s)
38. Interact independently with regulatory agencies
39. Develop and provide training on complex manufacturing processes
40. Perform Manufacturing review and approval of critical documents
41. Develop process validation protocols
42. Maintain good housekeeping and clean and sanitize classified areas as required.
43. Analyze complex problems and resolve and implement solutions
You will need to have:
1. Able to work within and adapt to complex electronic systems such as SAP and EQV
2. Able to read, write and converse in English
3. Have good working knowledge of MS Excel and Word
4. Ability to work in an intense, fast-paced work environment
5. Ability to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously
6. Ability to work independently and as part of a team
7. More than 2 years’ experience in a cGMP biopharmaceutical manufacturing environment
We would prefer for you to have:
1. BA/BSc in a scientific discipline or equivalent experience.
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