We're currently recruiting for an exciting opportunity with an award winning biopharmaceutical organization. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
1. Required to be compliant via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
2. Process Engineering & Validation
3. To lead and execute process engineering and validation activities to support the technical transfers
4. To lead and manage multiple Technical Engineering projects needed to support the business. This includes but is not limited to: Process improvements, capital projects and Lean projects across multi-disciplined functions which may also require global and network support and collaboration. Responsibility to lead an integrated project team in delivering the project business case and collaborating closely with cross functional teams to establish scope in improvement projects as we ramp up to a fully commercial site.
5. To manage and deliver on all technical/Validation/Quality Notifcations/Change control/Project support within the technical engineering team. Use scientific, product and process understanding as a basis for developing risk based approaches to investigations and trouble shooting.
6. Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g. Structured Root Cause Analysis, Statistical Process Control, Data driven decision making).
7. Drive collaboration between group functions and proactively looking for synergies and innovative ways of doing work. Constantly assessing our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant.
8. Act as a subject matter expert on (1) Equipment Design (2) Assisting in C&Q execution and planning; (3) Process design and validation.
9. Act as a liaison with both global engineering services and facilities as well as specialist vendors on process requirements to deliver projects
Education & Experience
10. Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business. Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects. Experience in leading through change would be an advantage.
11. In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing
12. Experience of executing and/or managing through equipment and process validation in a sterile environment
13. Good shipping/Filter/Cleaning validation knowledge required
14. Automation and MES knowledge
15. Have proven record of process improvement implementation
16. Proven record in planning and basic project management of a team to deliver on time/schedule and cost
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.