Job Type: Perm
Job ID: JO-1812-12204
Consultant: Karen McHugh
Do you have process development experience in Pharma Manufacturing including drug product development or technical transfer in the biopharmaceutical / bioprocessing field?
Would you like to work for a multinational Biopharmaceutical company based in Dublin?
If interested in this role, please forward your CV to email@example.com or call Karen on +353 1 7978720
Process Development Engineer - Drug Product - Dublin
JobContax is a preferred supplier to one of the world's leading BioPharma companies.
With major capital investment happening in their plant, this is an exciting time to join the team.
Reporting directly to the Manufacturing Operations Manager, the Process Development Engineer will
- lead the technology transfer of new product introductions
- Support operational readiness for Drug Product manufacturing
- will provide technical support for all manufacturing activities associated with the facility with an effort to control costs while also improving process efficiency.
Plant Operational Readiness
Lead the Drug Product Technical Transfer “Project”
Scope includes DP and Packaging
Delegate tasks and communicate priorities to team members
Own the DP Tech Transfer Schedule
Liaise with QC, QA, PD Lab, CAPEX Team, Logistics, Supply Chain and Manufacturing to ensure adherence to schedule and efficient troubleshooting
Understand regulatory requirements and communicate them to the project team
Lead the process validation
Provide technical support and direction to manufacturing personnel in order to ensure that the manufacturing and ancillary facilities can be operated to optimum efficiency and that Plant Turnarounds are executed in an efficient manner.
Support Plant operations team with achieving manufacturing schedule adherence.
Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services.
Continuous improvement with a cross functional focus is a core activity.
Investigate quality events as they arise and prepare deviation reports using site Trackwise system.
Participate in CAPEX projects associated with the facility, providing process knowledge input.
Complete required documentation relating to development and manufacturing activities in an accurate and timely manner.
Such documentation would include (but not be limited to) BMRs, SOP, Logbooks and EOPs.
Minimum 5 years experience in Pharma Manufacturing including Technical Transfer
Experience of OSD Drug Product Processes essential
Experience of Capsule Filling, Blending and Primary Packaging desirable
Experience of High Containment Operation desirable
Excellent written and verbal communication skills
Flexible, willing and positive attitude / mind-set
Excellent planning, scheduling and prioritisation ability
Excellent documentation skills and attention to detail.
Excellent knowledge of Microsoft products and systems skills.
Strong Quality orientation.
Ability to work under pressure & managing conflicting tasks at the same time.
Attention to detail is critical.
Ability to work well with others to achieve organisational goals.
Total Package €50k - €75k
Excellent benefits package
Performance Related Bonus
Paid Maternity/Paternity Leave
Educational Assistance Programme
Zero Absence Award
Talent & Development Programme
Occupational Health & Wellness Programme
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact Karen by e-mail firstname.lastname@example.org or phone +353-1-7978720
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