- A new opportunity has arisen for a Senior Process Engineer to join our client’s pharmaceutical site in Co. Cork.
- Provide process engineering services in support of the design and commissioning & qualification of a significant expansion to an existing bulk vaccine processing facility.
- The job-holder works with the Process Engineering Team as a client owner representative to deliver Project Objectives.
- The Senior Process Engineer will manage cross functional teams to deliver the following scope;
- Equipment package design, factory acceptance testing, installation and commissioning
- Packages may include Autoclave, COP/SOP skid, WFI storage and distribution, Downflow Booth, Glovebox modifications, wave rockers and miscellaneous ancillary equipment.
Core Duties and Responsibilities:
- Support GES Process Lead to implement a Process Design based on the scope of Process Requirements outlined in the project scope of work.
- Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in C&Q deliverables.
- Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
- Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
- Oversee C&Q progression by a partner firm.
- Ensure Global and Co. Cork site engineering standards, procedures and practices are followed.
- Support GES C&Q Lead to coordinate preparation and, at times, lead C&Q field execution.
- Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
- Manage installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
- Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the site Manufacturing Network as required to support Project.
- The job-holder will also undertake Project Engineering duties including:
- preparation of project related deliverables such as schedules, work plans, equipment cost tracking
- coordination of project activities between stakeholders.
Minimum Qualifications and Experience:
- Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Chemical or Biochemical Engineering or equivalent discipline; equivalent is defined as a Biotechnology or Industrial Chemistry Degree with basic the elements of chemical/biochemical engineering fundamentals as applied to biotechnology/bioprocessing.
- Minimum of 7 years post academic process engineering experience in relevant biopharmaceutical processing design, construction & start-up environment.
- Demonstrated ability to lead / influence teams in matrix environment
- Excellent communication/presentation/organizational skills
- In depth understanding of process engineering and technologies pertinent to unit process and utility operations for a bulk vaccine processing facility.
- Knowledge on the application of single use technologies
- Knowledge of DCS/PLC process control platforms and industry SDLC methodology
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland.
+353 21 2066178
Please note, we do not require agency assistance with this role.