Lead Project Engineer

Project Engineer
11 month contract
On site - Carlow

I am currently looking for a Project Engineer to join the Technical Engineering Department for a growing biopharmaceutical manufacturer in Carlow. You will help lead Process Improvements, capital projects and lean projects across multiple functions

The ideal candidate will have experience as a Capital Projects Team Lead for large capital projects (>$5MM).

Responsibilities

• Manage projects from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects.
• Maintain contact with the Project Sponsors to ensure engineering solution development remains aligned with the project’s business case.
• 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.
• Coordinate and present of the typical project Stage Gates to off-site Capital Approval Committee.
• Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects.
• 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.
• Collaborate closely with cross functional teams to establish scope in improvement projects as we ramp up to a fully commercial site.
• Act 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).
• Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. 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.
• Integration of Computer Systems Validation activities, in collaboration with Automation/IT partners, into required projects
• Drive collaboration between groups within the Technical Engineering function proactively looking for synergies and innovative ways of doing work.
• Constantly assess our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant.
• Act 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.
• Work collaboratively to drive a safe and compliant culture.
• May be required to perform other duties as assigned.

• Bachelors degree in Scientific, technical or Engineering field
• At least 5 years experience in a Project/Process/Validation/CQV Engineering role
• Project management skills
• People management skills
• In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing
• Experience of executing and/or managing through equipment and process design and validation in a sterile environment
• Good shipping/Filter/Cleaning validation knowledge required
• Proven record in planning and basic project management of a team to deliver on time/schedule and cost
• Proven contractor and vendor management

• Experience as a Capital Projects Team Lead for large capital projects (>$5MM) preferable.
• Considerable experience in a comparable role; experience operating as a senior professional and adding considerable value to the business.
• Process engineering and/or validation experience in a sterile manufacturing environment
• Proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects.
• Experience in leading through change
• Lean Six Sigma Methodology experience
• Experience in audit preparation and execution