ref. 01200
Project Process Engineer Exciting opportunity for a Project Engineer with our Carlow based biopharmaceutical client. This is an 11-Month contract role.
As Project Engineer you will be responsible for leading multiple Engineering projects from scope development, design, build/install and qualify through to handover to operations for key Engineering projects at Carlow. This includes but is not limited to Process improvements, Lean projects and capital projects across multi-disciplined functions which may also require global and network support and collaboration.
Responsibilities
• Manage multiple projects at Carlow from scope development, design, build/install and qualify through to handover to operations for key Engineering projects at Carlow.
• Develop risk-based approaches to investigations and troubleshooting that will feed into future projects using scientific, product and process understanding as a basis for it.
• Enhance project scope, cost, and delivery time schedule for projects, working and collaborating closely with NPI leads to ensure integration into ongoing Validations and/or technical transfers.
• Responsible for equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. And requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation.
• Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
• Active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate for continuous improvement.
• Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on site activities.
• Act as an intermediary with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business.
• Work with multiple partners (e.g., Company network groups, third parties, vendors, quality, donor sites, Supply chain, IPT).
• Presentations and reporting out on progress of projects to stakeholder as required.
• May be required to perform other duties as assigned.
Requirements
• Bachelor's degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline.
• Lean Six Sigma Methodology experience desired; Green Belt preferable.
• Considerable experience in a similar role; would typically have experience operating as a senior professional.
• Previous engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team through sustaining operations and technical transfer projects.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Thoroughly knowledge and experience of Sterile filling processes and equipment especially aseptic processing.
• Proficiency in Microsoft Office and job-related computer applications required.
• Experience of executing and/or managing through equipment and process design and validation in a sterile environment.
• Automation and MES knowledge.
• Experience in audit preparation and execution desired.
• Have a proven record of project management of change in a commercial site and process improvement implementation.
The suitable candidate will typically have prior related project engineering experience; ideally in manufacturing, preferably GMP Setting with process engineering and/or validation experience in a sterile manufacturing environment.
#J-18808-Ljbffr