Seeking a seasoned professional to lead process improvements and capital projects. Develop and maintain project scope, budget, and timelines with the core team. Ensure engineering solution development remains aligned with the business case by maintaining contact with project sponsors.
* Manage projects from scope development through handover to operations for key Technical Engineering projects
* Maintain communication with project sponsors to ensure engineering solutions align with business objectives
* Develop and maintain project scope, budget, and timelines in collaboration with the core team
* Present project stage gates to stakeholders
* Apply scientific understanding as a basis for developing risk-based approaches to investigations and troubleshooting
* Develop project scope, cost, and delivery time schedule for all Tech Eng projects
* Collaborate with cross-functional teams to establish scope in improvement projects
* Act as subject matter expert on equipment design and qualification, C&Q protocol development, and project implementation
* Sponsor lean six sigma and standard work within the technical engineering Team
* Drive continuous improvement through active participation in projects and system failure investigations
* Implement corrective action through change management systems
* Collaborate between groups within the Technical Engineering function to find synergies and innovative ways of doing work
* Constantly assess systems and processes to identify areas for improvement
* Liaise with global engineering services and facilities as well as specialist vendors
* Work collaboratively to drive a safe and compliant culture
Requirements:
Must-Haves:
* Bachelor's degree in Scientific, Technical, or Engineering field
* At least 5 years' experience in 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 executing and/or managing 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
Desirables:
* Experience as Capital Projects Team Lead for large capital projects (>$5MM)
* Considerable experience in a comparable role
* 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 leading through change
* Lean Six Sigma Methodology experience
* Experience in audit preparation and execution