Ref. 01238
Process Project Engineer
Asset Recruitment is recruiting a Process Project Engineer for a contract role (initially 11-Month duration), on behalf of our client, a growing pharmaceutical manufacturer in Carlow.
You will join the Technical Engineering Department, leading an integrated project team in delivering the project business case. You will be involved in Process Improvements, capital projects and lean projects across multiple functions.
Responsibilities
• Manage projects from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects.
• Responsible, with the Project Manager, for the development and maintenance of the scope, budget and timelines. Adequately resource core team in support of scope and schedule targets.
• Maintain direct contact with the Project Sponsors to ensure engineering solution development remains aligned with the project’s business case.
• Coordinate and present of the typical project Stage Gates to off-site Capital Approval Committee.
• Develop project scope, cost and delivery time schedule for all Tech Eng projects, working and collaborating closely with technical engineering leads to ensure integration into ongoing Validations and/or Technical transfers.
• Work with cross functional teams to establish scope in improvement projects as we ramp up to a fully commercial site.
• Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects.
• Serve as a subject matter expert on: 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.
• Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g. Structured Root Cause Analysis, Statistical Process Control, Data driven decision making).
• Active participate in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate to drive and support continuous improvement.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
• Integrate Computer Systems Validation activities into required projects, in collaboration with Automation/IT partners.
• Foster collaboration between groups within the Technical Engineering function proactively looking for synergies and innovative ways of doing work.
• Continuously evaluate systems and processes to identify opportunities for smarter, more efficient and compliant operations.
• Serve as a liaison 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.
• May be required to perform other duties as assigned.
Requirements
• The ideal candidate will have experience as a Capital Projects Team Lead for large capital projects (>$5MM).
• Bachelor’s degree in a Science, technical or Engineering discipline.
• 7+ years’ experience in a similar role (Process/Project/CQV activities)
• Would typically have experience operating as a senior professional and adding considerable value to the business. Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects. Experience in leading through change would be an advantage.
• Good knowledge of shipping/Filter/Cleaning validation.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Automation and MES knowledge.
• Proficiency in Microsoft Office and job-related computer applications required
• Excellent communication, presentation and interpersonal skills.
• Proven contractor and vendor management skills.
• Proven record in planning and basic project management of a team to deliver on time/schedule and cost.
Desirable
• Lean Six Sigma Methodology experience.
• Experience in audit preparation and execution.
• Knowledge of QbD/CPV.
#J-18808-Ljbffr