Process Equipment Engineer II – GMP Manufacturing

BeiGene, Ltd.; Hopewell (VA); Vor Ort; USD 96.000 - 131.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision

401(k)

Paid Time Off

Wellness

Zusammenfassung

BeOne Medicines seeks an experienced engineer to join our Hopewell, NJ team, supporting a new small molecule manufacturing facility. You will manage commissioning, qualification, and ongoing maintenance, ensuring 24x7 operations in a GMP setting.

Collaboration with quality and manufacturing teams will be essential, with visible impact on site reliability and compliance. The role requires a BS (or higher) in Engineering and 4+ years in GMP environments, with strong project management,

Qualifikationen

• BS or higher in engineering or related discipline.
• Minimum of 4+ years of equipment and facility support in GMP environment.
• Strong understanding of Quality in GMP including GDP, Deviation and CAPA management.
• Excellent communication and interpersonal skills with cross-functional collaboration.
• Able to manage multiple priorities under tight timelines.

Aufgaben

• Provide SME input into Equipment and Facility for Small Molecule projects.
• Oversee commissioning, qualification and validation of systems.
• Develop and maintain procedures and preventive maintenance plans.
• Collaborate with Global Engineering to hit project milestones.
• Lead in fault analysis and remediation and support operations.

Kenntnisse

Project management

GMP knowledge

Analytical problem-solving

Communication

Cross-functional collaboration

Ausbildung

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

CMMS / Maximo

Microsoft Project

AutoCAD

Smartsheet

Power BI / SharePoint

Jobbeschreibung

BeOne Medicines seeks an experienced engineer to join our Hopewell, NJ team, supporting a new small molecule manufacturing facility. You will manage commissioning, qualification, and ongoing maintenance, ensuring 24x7 operations in a GMP setting.

Collaboration with quality and manufacturing teams will be essential, with visible impact on site reliability and compliance. The role requires a BS (or higher) in Engineering and 4+ years in GMP environments, with strong project management,