Overview
In this role you will lead the technical design and delivery of facility, utility and equipment projects within our site portfolio. You will translate business needs into clear engineering concepts and drive decision-making through feasibility studies and risk assessments. You will safeguard quality and regulatory compliance, and coordinate with external partners to ensure successful project outcomes. You will work closely with cross-functional stakeholders to optimize technical solutions and enable faster, compliant product delivery. Join us to shape critical infrastructure that supports cutting-edge cancer therapies at Kite.
Verantwoordelijkheden- Lead the technical definition, design and delivery of facility, utility and equipment projects
- Translate needs and constraints into engineering concepts, scopes and solutions
- Lead feasibility studies and option assessments with external partners and present recommendations
- Develop or coordinate technical specifications, design requirements and tenders
- Review designs and deliverables from partners, vendors and contractors
- Ensure compliance with cGMP, EHS, site procedures and regulatory requirements
- Own or input to quality records (Change Controls, risk assessments, deviations, CAPA)
- Communicate status, priorities, risks and decisions to project managers and site stakeholders
- Monitor contractor execution and acceptance of deliverables
- Lead troubleshooting and root cause analysis for project or system issues
- Manage engineering documentation and drawings lifecycle
- Contribute to site engineering standards and knowledge sharing
Belangrijkste vereisten- Bachelor in Engineering, Technology or related technical discipline
- At least 6 years of engineering experience in a cGMP commercial manufacturing environment or similar
- Experience leading technical design and delivery of facility, utility or equipment projects
- Ability to translate complex technical issues into practical solutions
- Experience preparing or reviewing engineering specifications, feasibility studies and design packages
- Knowledge of cGMP manufacturing, change management, risk, deviations, CAPA and regulatory requirements
- Knowledge of equipment and system lifecycle activities including qualification, handover and readiness
- Strong troubleshooting and structured problem-solving skills
- Ability to influence across functions and manage competing priorities
- Self-starter and team player with strong verbal, written and interpersonal skills
- Strong attention to detail and organizational skills
- Preferred: AutoCAD, Revit experience
- Working with external design partners
- strong communication
- influencing cross-functionally
- problem-solving
- AutoCAD
- Revit
- cGMP
Solliciteren