Job Details

Job Description

• Design, procure, and implement Drug Product equipment
• Create design specifications for Drug Product equipment to meet facility needs
• Request and evaluate quotes from equipment vendors
• Oversee and collaborate with vendors during design and fabrication processes
• Manage and support FAT (Factory Acceptance Test), SAT (Site Acceptance Test), and start-up activities
• Integrate equipment design with facility and utility requirements for a Greenfield site
• Collaborate with cycle development and CQV teams to hand over equipment to end users

Requisitos
Habilidades duras

• Drug Product equipment design and implementation
• Utility and process equipment design
• FAT, SAT, and start-up procedures
• Knowledge of cGMP, OSHA, and EPA regulations
• Project management and organizational planning
• English fluency (written and spoken)
• Ability to manage multiple projects simultaneously
• Engineering experience with larger CAPEX projects

Habilidades blandas

• Strong leadership
• Teamwork and collaboration (cross-functional)
• Excellent communication (written and verbal)
• Problem-solving and decision-making
• Attention to detail

Time management and prioritization

Conocimientos y experiencia

• More than 5 years of experience in pharmaceutical/biotech operations
• Experience in regulated environments (cGMP, OSHA, EPA)
• Design or owner's experience in manufacturing processes
• Working knowledge of Drug Product processes and equipment
• Experience with equipment vendors and procurement processes
• Experience working on Greenfield facility projects
• Willingness and ability to travel
• On-site work in North Carolina, USA

Profesiones

• Bachelor's or Master's degree in Engineering (Preferably in Mechanical or Chemical Engineering)

To help us streamline our process, please only apply if you meet the listed requirements and they are reflected in your CV. If not, we encourage you to stay tuned for future opportunities where you can shine. Thank you for your understanding!