Job Purpose: Dublin based Oral Solid Dose Pharmaceutical client require a Senior Project Engineer for their Capital Projects Group.
They will also manage the delivery of the key documentation required for a best-practice Stage Gate managed process, including (but not limited to) a detailed Project Execution Plan and cost estimate.
They will manage the full range of activities associated with the project life-cycle from cradle to grave: URS; Concept; Basis of Design; Detailed Design; Construction; Commissioning and Qualification.
Responsibilities: Project management and coordination of same within the production environment.
Installation, Commissioning, and Validation of manufacturing plant equipment and processes.
Troubleshooting and debug of equipment under the site change control system.
Leading the generation of lifecycle documentation for process equipment and associated systems.(URS, FDS, DDS, FAT, SAT, IQ/OQ, Risk Assessments, procedures etc).
Supporting Engineering functions, such as Factory Acceptance Testing, Commissioning, Qualification, etc.
applying good project management and Engineering principles.
Ensuring Projects are handed over in a controlled manner with manuals, training maintenance systems and site master drawings updated.
Optimisation of new and existing processes to achieve production output targets.
Provide routine technical support for assigned process and packaging activities.
Review line metrics and provide technical solutions to increase operational efficiency.
Collaborate significantly with internal/external functions and suppliers to finalize process and equipment design.
Follow c GMP guidelines, safety procedures, and SOPs at all times.
The Person/Requirement The successful applicant must possess the following knowledge, skills, qualifications and experience.
A 3rd level Engineering (honours) degree in a relevant field of study.
E.
G Mechanical, Process or Chemical Engineering (other disciplines may also be considered) 5+ Years experience in Pharmaceutical Project Engineering with OSD experience an advantage Significant exposure to Technical Investigations and Process Optimisation initiatives and projects.
Excellent time management skills with ability to prioritise and work to strict deadlines.
Excellent leadership (Projects), interpersonal, presentation and communications skills with the ability to work within cross-functional teams.
Skills: OSD Engineering Project Engineer Pharma Pharmaceutical Project Management FAT