KPC International - Excellence from Concept to Completion
KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.
We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life changing products to patients.
Process Engineer 111 Carlow
Responsibilities
* Act as Package owner for new process equipment and upgrades to existing process equipment.
* Manage vendors for critical equipment detailed design, fabrication, installation on site and delivery up to PQ completion.
* Develop Process Flow Diagrams, P&IDs, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.
* Facilitate teams to complete process safety deliverables including PHA (Hazops).
* Ensure MSD Global engineering standards, procedures and practices are followed in the design development.
* Work as part of a cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
* Ensure all project stakeholders are consulted on key process suite activities.
* Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
* Support GES C&Q Lead to coordinate preparation and 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 MSD Manufacturing Network as required to support Project.
* The successful candidate may also undertake Project Engineering duties including preparation of project related deliverables such as schedules, work plans, or equipment cost tracking.
Skills And Qualifications
* Minimum qualification B.Sc. or M.Sc./ M. Eng Degree in Chemical or Biochemical Engineering or equivalent discipline.
* Minimum of 5 years post academic process engineering experience. Aseptic/sterile processing design, construction & start-up experience would be preferred.
* Demonstrated ability to lead / influence teams in matrix environment
* Excellent communication/presentation/organizational skills
* In depth understanding of process engineering and technologies pertinent to formulation and filling unit operations.
* Knowledge of SDLC methodology
KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others.
KPC – International is an Equal Opportunity Employer.